President Trump on Monday invoked a law from 1807 allowing him to
send military forces to states rocked by unrest over the death of George
Floyd in a sudden White House Rose Garden address interrupted by the
sounds of protestors being cleared out by police nearby.
“We cannot allow the righteous cries of peaceful protesters to be
drowned out by an angry mob,” Trump said, declaring himself the
“president of law and order” while blaming extremist groups such as Antifa for the unrest.
“I am mobilizing all available federal resources, civilian and
military, to stop rioting and looting, to end the destruction,” he said,
immediately mobilizing the Insurrection Act of 1807, which allows him
to deploy troops anywhere across the nation — the first time its been
invoked in more than 200 years.
“If a city or state refuses to take the actions that are necessary to
defend the life and property of their residents, then I will deploy the
United States military and quickly solve the problem for them,” Trump
said of the act.
Under the Civil War-era Posse Comitatus Act, federal troops are
prohibited from performing domestic law enforcement actions such as
making arrests, seizing property or searching people. In extreme cases,
however, the president can invoke the Insurrection Act, also from the
Civil War, which allows the use of active-duty or National Guard troops
for law enforcement.
The president’s last-minute address was an incredible juxtaposition
to the scene outside, where a series of military vehicles rolled out
front on Pennsylvania Avenue and military police and law enforcement
clashed with protesters at Lafayette Park, firing tear gas, flash bangs,
rubber bullets and pepper spray on a large but peaceful crowd.
Trump described the scenes of violent rioting and looting which have
rocked the nation for the past week as a “total disgrace” and said
anyone who didn’t respect curfew orders would be “prosecuted to the
fullest extent of the law.”
“I am taking these actions today to reaffirm resolve and with a true
and passionate love for our country, by far our great days lie ahead,”
he said as chaos unfolded in the streets around the White House.
Following his address, Trump walked out of the front of the White
House gates, through Lafayette Park to Washington’s historic St John’s
Episcopal Church which was partly destroyed in a fire lit by rioters on
Sunday evening.
The president posed for photos outside the boarded-up church, holding
a Bible and flanked by his White House staff including press secretary
Kayleigh McEnany and chief of staff Mark Meadows where protesters were
demonstrating just moments before.
The police made the aggressive advance on more than a thousand
protesters outside the executive address following days of unrest across
the nation over the death of George Floyd in police custody.
Earlier Monday, President Trump lashed into governors
for their response to the week-long crisis — calling them “weak” and
telling them to needed to take control of the unrest following Floyd’s
death.
https://nypost.com/2020/06/01/president-trump-mobilizing-us-military-to-end-george-floyd-riots/
Monday, June 1, 2020
FDA Action Alert This Week: Foamix, Immunomedics and Merck
Although the U.S. Food and Drug Administration (FDA)
is very busy dealing with emergency use approvals for diagnostics and
possible treatments for COVID-19, it is still evaluating and approving
therapies for non-COVID-19 indications. Here’s a look at this week’s
calendar.
Foamix’s FMX103 for Rosacea
Foamix, now a subsidiary of Menlo Therapeutics, had a target action date of June 2, 2020 for FMX103, a topical treatment for moderate-to-severe papulopustular rosacea. The FDA approved it on Friday, May 29, under the brand name Zilxi.
On February 18, the company announced integrated efficacy data on the two pivotal Phase III trial of FMX103 (minocycline, 1.5% foam). Those studies compared FMX103 to vehicle, which is essentially a placebo. The studies were identical with 1,522 subjects, and 1,009 received FMX103 and 513 received vehicle. The data evaluated the results after 12 weeks of once-a-day application.
In the combined analysis, FMX103 showed statistically significant benefit compared to vehicle foam on both primary endpoints, which were reduction of inflammatory lesion counts from Baseline to Week 12 and IgA treatment success defined as an IGA score of 0 (clear) or 1 (almost clear) and at least a 2-grade improvement at Week 12.
Papulopustular rosacea is a chronic skin disease causing inflammatory lesions on the nose, cheeks, chin and forehead.
“This is the only product containing minocycline approved by the FDA for rosacea,” said Iain Stuart, Menlo’s chief scientific officer. “The availability of a novel topical formulation of this molecule underscores our efforts to provide innovative treatment options for patients who suffer from difficult to treat skin conditions.”
The Foamix and Menlo merger completed on March 9. Foamix’s management team will run the company, led by David Domzalski as chief executive officer.
Immunomedics’ Sacituzumab Govitecan for Triple-Negative Breast Cancer
Immunomedics had a target action date of June 2 for its resubmitted Biologics License Application (BLA) for sacituzumab govitecan for treatment of patients with metastatic-negative breast cancer (mTNBC) who received at least two previous therapies for metastatic disease. The FDA approved the drug on April 22 under the name Trodelvy. It is the first antibody-drug conjugate (ADC) approved by the FDA specifically for relapsed or refractory mTNBC and also the first FDA-approved anti-Trop-2 ADC.
The drug was granted Breakthrough Therapy Designation and Priority Reviews. It was approved under the agency’s Accelerated Approval Program based on the objective response rate (ORR) and duration of response (DoR) observed in a single-arm, multicenter Phase II trial. Continued approval is based in verification of clinical benefit in the confirmatory Phase III ASCENT trial, which was recently halted by the independent Data Safety Monitoring Committee after compelling evidence of efficacy was observed across multiple endpoints.
“The approval of Trodelvy, the first ADC approved specifically for metastatic TNBC, an aggressive cancer with a poor prognosis and few effective therapies, will give clinicians a novel tool for treating patients with this disease,” said Aditya Bardia, director of Precision Medicine at the Center for Breast Cancer, Massachusetts General Hospital Cancer Center and assistant professor of Medicine at Harvard Medical School. Bardia was the lead investigator of the Phase II trial.
Bardia went on to say, “In our trial, Trodelvy demonstrated clinically meaningful responses in patients with difficult-to-treat metastatic TNBC and moves the needle towards better outcomes for patients with metastatic breast cancer.”
Merck’s Recarbrio for Bacterial Pneumonia
Merck has a target action date of June 4 for its supplemental New Drug Application (sNDA) for Recarbrio (imipenem, cilastatin, and relebactam) for adults with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) caused by certain susceptible Gram-negative microorganisms. The submission was built on data from the pivotal Phase III RESTORE-IMI 2 trial in adults with HABP/VABP.
The drug was originally approved in July 2019 by the FDA for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis and complicated intra-abdominal infections (cIAI) caused by susceptible Gram-negative bacteria in adults with limited or no alternative treatment options.
“This submission reinforces Merck’s continued dedication to researching and developing potential antibiotic treatment options which address unmet medical needs,” said Nicholas Kartsonis, senior vice president, clinical research, infectious diseases and vaccines, Merck Research Laboratories, in a February 2020 announcement. “We are unwavering in our commitment to evaluate treatments for infections caused by certain Gram-negative pathogens.”
https://www.biospace.com/article/fda-action-alert-foamix-immunomedics-and-merck/
Foamix’s FMX103 for Rosacea
Foamix, now a subsidiary of Menlo Therapeutics, had a target action date of June 2, 2020 for FMX103, a topical treatment for moderate-to-severe papulopustular rosacea. The FDA approved it on Friday, May 29, under the brand name Zilxi.
On February 18, the company announced integrated efficacy data on the two pivotal Phase III trial of FMX103 (minocycline, 1.5% foam). Those studies compared FMX103 to vehicle, which is essentially a placebo. The studies were identical with 1,522 subjects, and 1,009 received FMX103 and 513 received vehicle. The data evaluated the results after 12 weeks of once-a-day application.
In the combined analysis, FMX103 showed statistically significant benefit compared to vehicle foam on both primary endpoints, which were reduction of inflammatory lesion counts from Baseline to Week 12 and IgA treatment success defined as an IGA score of 0 (clear) or 1 (almost clear) and at least a 2-grade improvement at Week 12.
Papulopustular rosacea is a chronic skin disease causing inflammatory lesions on the nose, cheeks, chin and forehead.
“This is the only product containing minocycline approved by the FDA for rosacea,” said Iain Stuart, Menlo’s chief scientific officer. “The availability of a novel topical formulation of this molecule underscores our efforts to provide innovative treatment options for patients who suffer from difficult to treat skin conditions.”
The Foamix and Menlo merger completed on March 9. Foamix’s management team will run the company, led by David Domzalski as chief executive officer.
Immunomedics’ Sacituzumab Govitecan for Triple-Negative Breast Cancer
Immunomedics had a target action date of June 2 for its resubmitted Biologics License Application (BLA) for sacituzumab govitecan for treatment of patients with metastatic-negative breast cancer (mTNBC) who received at least two previous therapies for metastatic disease. The FDA approved the drug on April 22 under the name Trodelvy. It is the first antibody-drug conjugate (ADC) approved by the FDA specifically for relapsed or refractory mTNBC and also the first FDA-approved anti-Trop-2 ADC.
The drug was granted Breakthrough Therapy Designation and Priority Reviews. It was approved under the agency’s Accelerated Approval Program based on the objective response rate (ORR) and duration of response (DoR) observed in a single-arm, multicenter Phase II trial. Continued approval is based in verification of clinical benefit in the confirmatory Phase III ASCENT trial, which was recently halted by the independent Data Safety Monitoring Committee after compelling evidence of efficacy was observed across multiple endpoints.
“The approval of Trodelvy, the first ADC approved specifically for metastatic TNBC, an aggressive cancer with a poor prognosis and few effective therapies, will give clinicians a novel tool for treating patients with this disease,” said Aditya Bardia, director of Precision Medicine at the Center for Breast Cancer, Massachusetts General Hospital Cancer Center and assistant professor of Medicine at Harvard Medical School. Bardia was the lead investigator of the Phase II trial.
Bardia went on to say, “In our trial, Trodelvy demonstrated clinically meaningful responses in patients with difficult-to-treat metastatic TNBC and moves the needle towards better outcomes for patients with metastatic breast cancer.”
Merck’s Recarbrio for Bacterial Pneumonia
Merck has a target action date of June 4 for its supplemental New Drug Application (sNDA) for Recarbrio (imipenem, cilastatin, and relebactam) for adults with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) caused by certain susceptible Gram-negative microorganisms. The submission was built on data from the pivotal Phase III RESTORE-IMI 2 trial in adults with HABP/VABP.
The drug was originally approved in July 2019 by the FDA for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis and complicated intra-abdominal infections (cIAI) caused by susceptible Gram-negative bacteria in adults with limited or no alternative treatment options.
“This submission reinforces Merck’s continued dedication to researching and developing potential antibiotic treatment options which address unmet medical needs,” said Nicholas Kartsonis, senior vice president, clinical research, infectious diseases and vaccines, Merck Research Laboratories, in a February 2020 announcement. “We are unwavering in our commitment to evaluate treatments for infections caused by certain Gram-negative pathogens.”
https://www.biospace.com/article/fda-action-alert-foamix-immunomedics-and-merck/
Pfizer Analyst Takes Stock Of Negative Breast Cancer Data, 2025 Goals
Pfizer Inc. PFE 6.95% shares were declining steeply Monday after the company said a Phase
3 study dubbed PALLAS that evaluated its Ibrance with standard adjuvant
endocrine therapy in HR+, HER-, early stage breast cancer study is
unlikely to hit the primary goal, citing efficacy and futility analysis
done by an Independent Data Monitoring Committee.
The analyst said she expects the consensus sales estimate for Ibrance to come down to reflect a lower opportunity.
Pfizer had earlier said the adjuvant opportunity could double the eligible patient population for Ibrance, she said.
Ibrance is already approved in the U.S. for treating adult patients with HR+, HER- advanced breast cancer.
The Street projects that Ibrance sales will grow from $5 billion in 2019 to $11.5 billion by 2025, Chen said.
The analyst estimates worldwide Ibrance sales of $8.6 billion in 2025, assuming a 33% probability of success for the PALLAS and PENELOPE-B studies.
The PENELOPE-B study is on track to readout by the second half of 2020, she said.
Yet with mixed data from the PALLAS and a Phase 2 study dubbed PALLET, expectations for the PENELOPE-B study will be modest, Chen said.
Despite the disappointing news, Pfizer said it remains confident in its ability to deliver on its goal of at least 6% revenue CAGR through 2025, according to Cantor Fitzgerald.
This assertion will hardly be credible to investors, the analyst said.
“We think PFE’s ability to hit its CAGR target will depend more than ever on its ability to deliver strong growth from its in-line portfolio as well as contributions from the pipeline/new product launches.”
https://www.benzinga.com/analyst-ratings/analyst-color/20/06/16151451/pfizer-analyst-takes-stock-of-negative-breast-cancer-data-pharma-giants-2025-goals
The Pfizer Analyst
Cantor Fitzgerald analyst Louise Chen maintained an Overweight rating on Pfizer shares with a $53 price target.The Pfizer Thesis
The adjuvant opportunity for the breast cancer drug Ibrance is being viewed by investors as a key growth driver for Pfizer, Chen said in a Friday note. (See her track record here.)The analyst said she expects the consensus sales estimate for Ibrance to come down to reflect a lower opportunity.
Pfizer had earlier said the adjuvant opportunity could double the eligible patient population for Ibrance, she said.
Ibrance is already approved in the U.S. for treating adult patients with HR+, HER- advanced breast cancer.
The Street projects that Ibrance sales will grow from $5 billion in 2019 to $11.5 billion by 2025, Chen said.
The analyst estimates worldwide Ibrance sales of $8.6 billion in 2025, assuming a 33% probability of success for the PALLAS and PENELOPE-B studies.
The PENELOPE-B study is on track to readout by the second half of 2020, she said.
Yet with mixed data from the PALLAS and a Phase 2 study dubbed PALLET, expectations for the PENELOPE-B study will be modest, Chen said.
Despite the disappointing news, Pfizer said it remains confident in its ability to deliver on its goal of at least 6% revenue CAGR through 2025, according to Cantor Fitzgerald.
This assertion will hardly be credible to investors, the analyst said.
“We think PFE’s ability to hit its CAGR target will depend more than ever on its ability to deliver strong growth from its in-line portfolio as well as contributions from the pipeline/new product launches.”
https://www.benzinga.com/analyst-ratings/analyst-color/20/06/16151451/pfizer-analyst-takes-stock-of-negative-breast-cancer-data-pharma-giants-2025-goals
Lilly CEO on Covid Treatment Progress: ‘This Is An Important Bridge Therapy’
Drugmaker Eli Lilly And Co LLY 0.48% started a human study of a potential antibody treatment for COVID-19 patients, and CEO David Ricks said on Fox Business that it is the first of its kind.
Eli Lilly scientists collaborated with Canada-based AbCellera to engineer a treatment out of the “very best one or two” antibodies it can find out of millions of cells, the CEO said. The initial study will consist of less than 40 patients, and results are expected in a “couple of weeks,” he said.
The company expects to produce 100,000 or more doses that will be available in the fall, the CEO said.
During the pandemic’s peak, there were around 60,000 people in a hospital in the U.S., so 100,000 could treat every person, he said.
The company also wants to explore later on in the summer months how its treatment can be used among those most at risk and vulnerable.
“This is an important bridge therapy until a vaccination could arrive and even perhaps vaccination this kind of therapy could find an important use,” the CEO said.
https://www.benzinga.com/general/biotech/20/06/16151876/eli-lilly-ceo-talks-coronavirus-treatment-progress-this-is-an-important-bridge-therapy
Lilly’s Brand New Medicine
Eli Lilly’s medicine to treat COVID-19 patients is the first of its kind, as it consists of antibodies found in a recovered patient’s cells. In contrast, other drugs and therapies are merely “repurposed” from other uses, Ricks said.Eli Lilly scientists collaborated with Canada-based AbCellera to engineer a treatment out of the “very best one or two” antibodies it can find out of millions of cells, the CEO said. The initial study will consist of less than 40 patients, and results are expected in a “couple of weeks,” he said.
Lilly’s Production Timeline
Eli Lilly has already started the process of ramping up production for its hopeful therapy despite it being in the early stages of testing, Ricks said.The company expects to produce 100,000 or more doses that will be available in the fall, the CEO said.
During the pandemic’s peak, there were around 60,000 people in a hospital in the U.S., so 100,000 could treat every person, he said.
Important Treatment Before Vaccine
Eli Lilly wants to study how its medicine can be used to treat people to avoid the need of going to a hospital in the first place as part of an ambulatory treatment study.The company also wants to explore later on in the summer months how its treatment can be used among those most at risk and vulnerable.
“This is an important bridge therapy until a vaccination could arrive and even perhaps vaccination this kind of therapy could find an important use,” the CEO said.
https://www.benzinga.com/general/biotech/20/06/16151876/eli-lilly-ceo-talks-coronavirus-treatment-progress-this-is-an-important-bridge-therapy
Biotech Investors: Mark Your Calendar For June PDUFA Dates
Despite the FDA tied up with COVID-19-related activities, May turned
out to be a positive month for biopharma companies from the perspective
of drug approvals. Three new molecular entities were approved during the
month and several other drugs also received the nod.
Meanwhile, Blueprint Medicines Corp BPMC 1.68% faced disappointment at the FDA altar, as its NDA for avapritinib for treating fourth-line gastrointestinal stromal tumor was clamped with a complete response letter.
Here are the key PDUFA dates scheduled for the unfolding month.
Merck’s Antibiotic Combo Up Before FDA For Label Expansion
The company said in its first-quarter earnings release it has begun preparations for potential regulatory approval, hiring and training market access and sales teams and deploying MSLs. The company expects to commercialize the drug shortly after.
It has already been approved for the treatment of X-linked hypophosphatemia in adult and pediatric patients 6 months of age and older. The companies are now seeking label expansion to include the indication FGF23-related hypophosphatemia associated with phosphaturic mesenchymal tumors that cannot be curatively resected or localized.
The company resubmitted the application in late December, and the FDA acknowledged the resubmission in mid-January.
Selinexor was approved in July 2019 as a combo treatment option along with dexamethasone for the treatment of adult patients with relapsed refractory multiple myeloma, who have received at least four prior therapies.
Heron resubmitted the NDA in October 2019, and in February the company said the FDA extended the review period by three months, rendering the PDUFA data on June 26.
If approved HTX-011 will compete with Pacira Biosciences Inc’s PCRX 1.43% Exparel, Guggenheim Securities analyst Dana Flanders said in a recent note. Citing the firm’s post-operative pain survey, Flanders said HTX-011 is likely to see significant growth at the expense of Exparel. The analyst said price point may be key in driving significant uptake.
Mycapssa, or octreotide capsules, is an oral drug being evaluated for the maintenance therapy of adult patients with acromegaly. A complete response letter was issued by the FDA in April 2016, seeking an additional clinical trial to establish the efficacy. Following a resubmission in Dec. 2019, the FDA accepted the application in January, giving it a PDUFA date of June. 26.
Acromegaly is a hormonal disorder that is caused by the production of too much hormone by the pituitary gland during adulthood, causing bone size to increase.
https://www.benzinga.com/general/biotech/20/06/16135090/attention-biotech-investors-mark-your-calendar-for-june-pdufa-dates
Meanwhile, Blueprint Medicines Corp BPMC 1.68% faced disappointment at the FDA altar, as its NDA for avapritinib for treating fourth-line gastrointestinal stromal tumor was clamped with a complete response letter.
Here are the key PDUFA dates scheduled for the unfolding month.
Merck’s Antibiotic Combo Up Before FDA For Label Expansion
- Company: Merck & Co., Inc. MRK 1.41%
- Type of Application: sNDA
- Candidate: Recarbrio
- Indication: hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia
- Date: June 4
Viela Eyes Commercial Status With its Autoimmune Disorder Drug Approval
- Company: Viela Bio Inc VIE 2.71%
- Type of Application: BLA
- Candidate: inebilizumab
- Indication: neuromyelitis optica spectrum disorder, or NMOSD
- Date: June 11
The company said in its first-quarter earnings release it has begun preparations for potential regulatory approval, hiring and training market access and sales teams and deploying MSLs. The company expects to commercialize the drug shortly after.
Can Merck’s Wonder Cancer Drug Snag Another Approval
- Company: Merck
- Type of Application: sBLA
- Candidate: Keytruda
- Indication: solid tumors
- Date: June 16
- Merck announced April 7 FDA acceptance of the application with priority review. Keytruda as a monotherapy is being evaluated for treating adult and pediatric patients with unresectable or metastatic solid tumors with tissue tumor mutational burden-high, as determined by an FDA-approved test, who have progressed following prior treatment and who have no satisfactory alternative treatment options
Ultragenyx Seeks Label Expansion For Partnered Drug To Treat Low Serum Phosphate Levels
- Company: Ultragenyx Pharmaceutical Inc RARE 1.67% and Kyowa Kirin
- Type of Application: sBLA
- Candidate: burosumab
- Indication: hypophosphatemia
- Date: June 18
It has already been approved for the treatment of X-linked hypophosphatemia in adult and pediatric patients 6 months of age and older. The companies are now seeking label expansion to include the indication FGF23-related hypophosphatemia associated with phosphaturic mesenchymal tumors that cannot be curatively resected or localized.
Epizyme Looks To Strike It Rich With Another Tazemetostat Approval
- Company: Epizyme Inc EPZM 2.45%
- Type of Application: sNDA
- Candidate: tazemetostat
- Indication: follicular lymphoma
- Date: June 18
Can Second Time Be Charm For Nabriva?
- Company: Nabriva Therapeutics PLC – ADR NBRV 31.49%
- Type of Application: NDA
- Candidate: Contepo
- Indication: complicated urinary tract infection or cUTI
- Date: June 19
The company resubmitted the application in late December, and the FDA acknowledged the resubmission in mid-January.
Evoke Knocks The FDA Altar After A Prior Rejection
- Company: Evoke Pharma Inc EVOK 5.26%
- Type of Application: NDA
- Candidate: Gimoti
- Indication: diabetic gastroparesis
- Date: June 19
Karyopharm Blood Cancer Drug On Track For Second Approval?
- Company: Karyopharm Therapeutics Inc KPTI 7.41%
- Type of Application: sNDA
- Candidate: Selinexor
- Indication: relapsed or refractory diffuse large B-cell lymphoma
- Date: June 23
Selinexor was approved in July 2019 as a combo treatment option along with dexamethasone for the treatment of adult patients with relapsed refractory multiple myeloma, who have received at least four prior therapies.
Zogenix’s Hopes For No Jitters On Seizure Drug Review
- Company: Zogenix, Inc. ZGNX 1.48%
- Type of Application: NDA
- Candidate: Fintepla
- Indication: seizures associated with Dravet syndrome
- Date: June 25
- Zogenix’s regulatory filing for Fintelpa was accepted for priority review in November 2019, with a PDUFA date of March 25. The FDA extended the review period by three months to give itself time to look at the additional data provided by the company.
Heron Expects Gain From Pain Drug Review
- Company: Heron Therapeutics Inc HRTX 2.74%
- Type of Application: NDA
- Candidate: HTX-011
- Indication: post-operative pain
- Date: June 26
Heron resubmitted the NDA in October 2019, and in February the company said the FDA extended the review period by three months, rendering the PDUFA data on June 26.
If approved HTX-011 will compete with Pacira Biosciences Inc’s PCRX 1.43% Exparel, Guggenheim Securities analyst Dana Flanders said in a recent note. Citing the firm’s post-operative pain survey, Flanders said HTX-011 is likely to see significant growth at the expense of Exparel. The analyst said price point may be key in driving significant uptake.
Can Chiasma Cross The FDA Hurdle This Time Around?
- Company: Chiasma Inc CHMA 0.16%
- Type of Application: NDA
- Candidate: Mycapssa
- Indication: acromegaly
- Date: June 26
Mycapssa, or octreotide capsules, is an oral drug being evaluated for the maintenance therapy of adult patients with acromegaly. A complete response letter was issued by the FDA in April 2016, seeking an additional clinical trial to establish the efficacy. Following a resubmission in Dec. 2019, the FDA accepted the application in January, giving it a PDUFA date of June. 26.
Acromegaly is a hormonal disorder that is caused by the production of too much hormone by the pituitary gland during adulthood, causing bone size to increase.
Intercept’s Wait For NASH Drug May Not End
- Company: Intercept Pharmaceuticals Inc ICPT 1.77%
- Type of Application: NDA
- Candidate: Obeticholic acid
- Indication: fibrosis due to non-alcoholic steatohepatitis
- Date: June 26
- NASH has become a tough nut to crack for biotech companies, with no approved drug yet despite a plethora of ongoing research. Intercept filed the NDA in November 2019 following positive Phase 3 results from the GENERATE study. The PDUFA date, which was originally fixed as March 26, was extended by three months.
https://www.benzinga.com/general/biotech/20/06/16135090/attention-biotech-investors-mark-your-calendar-for-june-pdufa-dates
AstraZeneca, Merck Get CHMP Go for Lynparza in Pancreatic Cancer
AstraZeneca PLC and Merck & Co. Monday said the European
Medicines Agency’s Committee for Medicinal Products for Human Use
recommended approval of the cancer drug Lynparza in a form of pancreatic
cancer.
The drugmakers said the recommendation covers Lynparza as monotherapy for the maintenance treatment of adults with germline BRCA1/2 mutations who have metastatic adenocarcinoma of the pancreas and haven’t progressed after a minimum of 16 weeks of platinum treatment within a first-line chemotherapy regimen.
The indication now awaits approval from the European Commission, which generally follows the CHMP’s recommendations.
AstraZeneca and Merck in 2017 formed a collaboration to co-develop and co-commercialize Lynparza for multiple cancer types.
https://www.marketscreener.com/ASTRAZENECA-PLC-4000930/news/AstraZeneca-Merck-Get-CHMP-Positive-Opinion-for-Lynparza-in-Pancreatic-Cancer-30705274/
The drugmakers said the recommendation covers Lynparza as monotherapy for the maintenance treatment of adults with germline BRCA1/2 mutations who have metastatic adenocarcinoma of the pancreas and haven’t progressed after a minimum of 16 weeks of platinum treatment within a first-line chemotherapy regimen.
The indication now awaits approval from the European Commission, which generally follows the CHMP’s recommendations.
AstraZeneca and Merck in 2017 formed a collaboration to co-develop and co-commercialize Lynparza for multiple cancer types.
https://www.marketscreener.com/ASTRAZENECA-PLC-4000930/news/AstraZeneca-Merck-Get-CHMP-Positive-Opinion-for-Lynparza-in-Pancreatic-Cancer-30705274/
Coronavirus: Restrict toilet access on flights, new rules suggest
Air passengers should have
restricted access to toilets on flights as part of wide-ranging
coronavirus safety recommendations, a UN agency has said.
The International Civil Aviation Organization (ICAO) guidelines also
include limiting or suspending food and drink services on short-haul
flights.The new guidelines are designed to protect air passengers and workers from the Covid-19 virus as lockdown eases.
Airlines could see revenues plunge £314bn in 2020, the ICAO added.
The aviation industry has been struggling as lockdown measures around the world have limited flights and passenger numbers.
As those travel restrictions begin to ease, the ICAO has issued guidelines for governments, with the aim of airlines and airports having a unified response when trying to keep passengers and staff safe from coronavirus.
The ICAO stopped short of saying that passengers must be socially-distanced on planes, but it did say they should be seated separately “when occupancy allows it”.
Passengers should travel as lightly as possible, with small hand luggage stowed under their seat. Newspapers and magazines should be removed, and duty free sales should be temporarily limited, the UN’s civil aviation body said.
Access to toilets should also be restricted, the ICAO said. Where possible, one toilet should be set aside for use by cabin crew, and passengers should use a designated lavatory based on which seat they have.
‘Biometrics for duty free’
The new recommendations cover airports, aircraft, crew and cargo.In general, face masks should be worn in line with public health guidelines, and social distancing should be made possible where it is feasible, the UN body said.
Areas should be routinely cleaned, and passengers should be checked for signs of coronavirus, by screening temperatures, for example. Contact tracing methods should also be explored.
At airports, staff should have adequate personal protective equipment, which “could include gloves, medical masks, goggles or a face shield, and gowns or aprons,” the guidelines said.
Passengers should be encouraged to check-in before getting to the airport, and to use mobile boarding passes.
Airports should also use contactless technology, including facial and iris scanning, for “self-service bag drops, various queue access, boarding gates and retail and duty-free outlets”, the guidelines say.
“This will eliminate or greatly reduce the need for contact with travel documents between staff and passengers,” the UN agency added.
From the moment you arrive at the terminal building, armed with your pre-printed boarding pass and luggage tags, human contact will be limited, social distancing the norm. Masks will be obligatory, and supplies of hand sanitiser everywhere.
If you don’t like potentially intrusive technology, tough – ICAO suggests that “contactless biometrics such as facial or iris recognition ” should be used wherever possible, to reduce physical contact between staff and passengers.
And it continues on board the plane: there are instructions to “limit interaction on board” – so no striking up a conversation with your neighbour – to reduce or suspend food and drink services, and to restrict lavatory access.
What ICAO is trying to do here is create a common and consistent framework for the industry to follow around the world – allowing people to travel, while placating even the strictest health authorities.
It insists the new measures should be temporary.
But for the moment, anything that was left of the once-lauded romance of flying looks set to disappear in a pungent cloud of disinfectant.
Airlines and aerospace firms have been struggling amid the coronavirus crisis.
At the beginning of May, Virgin Atlantic said it would axe 3,000 jobs and quit Gatwick. Later in the month, engine-maker Rolls Royce said it would cut 9,000 jobs.
There has been a huge reduction in air travel, with daily flights down about 80% since the start of the year.
But now carriers are making plans to get airborne again, with plans to reintroduce some schedules.
https://www.bbc.com/news/business-52765157
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