China to add 56 drugs to price-slashing bulk-buy program

China has added 56 medicines, including some global blockbuster drugs, to its state bidding program aimed at procuring key treatments at big discounts in return for offering large-volume state contracts, a state agency said.

The procurement authorities released late on Wednesday the list of drugs open to the upcoming round of bidding.

It includes some products that contributed more than $1 billion each to foreign drugmakers’ sales in 2019 but face challenges from generic versions offered by local drugmakers.

They include AstraZeneca Plc’s heart disease treatment Brilinta, blood-thinning blockbuster Eliquis, jointly developed by Pfizer Inc and Bristol Myers Squibb Co, and Novartis AG’s diabetes drug Galvus.

Beijing has pledged to lower consumer costs of off-patent drugs by pushing forward a national scheme where drugmakers have to go through a bidding process and chop prices low enough to elbow out competitors to be eligible to sell their products at public hospitals in bulk.

The scheme helped China notch up more than 50% of price cuts on average from drugmakers at home and abroad in its previous bidding held in January.

While competition for older brands intensify, Novartis said in an earning call last week that new drug launches are expected to be a main driver of its growth in China.

“We will continue to support the Chinese government’s policies by actively introducing innovative medicines and therefore improving accessibility to benefit more patients in need,” a Novartis representative said in an email.

AstraZeneca and BMS didn’t respond to a request for comment, while Pfizer asked to get in touch with partner BMS for any queries regarding the inclusion of their drug.

For most products on the list, if only one company wins the bid to supply a certain drug, the winner can bag up to half of the total procurement volume in the first year, according to the plan. If a product has at least four bid winners, 80% of the volume can be shared.

Information about drug companies’ applications to participate in the upcoming bidding will be released on Aug. 20 in Shanghai, according to the plan.

https://www.marketscreener.com/ASTRAZENECA-PLC-4000930/news/China-to-add-56-drugs-to-price-slashing-bulk-buy-programme-31027765/

ASTRAZENECA Receives a Buy rating from Credit Suisse

Credit Suisse is positive on the stock with a Buy rating. The target price is being increased from GBX 9000 to GBX 9500.

https://www.marketscreener.com/ASTRAZENECA-PLC-4000930/news/ASTRAZENECA-Receives-a-Buy-rating-from-Credit-Suisse-31032366/

Portable, injectable clotting agent could treat trauma victims on the front lines

When it comes to traumatic injuries, it’s a race against time. A person with major hemorrhage can die from blood loss within minutes, so staunching the wound and getting them to a hospital as fast as possible is critical. Bleeding from the extremities can be slowed with compression but what about internal bleeding? In a hospital, internal bleeding can be controlled with the transfusion of clotting agents, such as platelets, but they require careful storage and refrigeration and can’t be carried by first responders. As a result, the majority of people who succumb to traumatic injuries outside a hospital die from treatable hemorrhages.

Now, researchers from the Harvard John A. Paulson School of Engineering and Applied Sciences (SEAS), in collaboration with Massachusetts General Hospital, Beth Israel Deaconess Medical Center, and Case Western Reserve University, report an injectable clotting agent that reduced blood loss by 97 percent in mice models. The freeze-dried agent, which has a physical consistency of cotton candy, can be stored at room temperature for several months and reconstituted in saline before injection.

The research is published in Science Advances.

“Our goal was to give first responders a tool to stop internal bleeding that could be easily carried in a backpack or stored in an ambulance and, once injected intravenously in hemorrhagic patients, stop internal bleeding for a period long enough to get the patient to a hospital,” said Samir Mitragotri, Hiller Professor of Bioengineering and Hansjorg Wyss Professor of Biologically Inspired Engineering at SEAS and senior author of the study.

Mitragotri is also a Core Faculty member at Harvard’s Wyss Institute for Biologically Inspired Engineering.

Mitragotri and his team developed a polymer-peptide conjugate called HAPPI (Hemostatic Agents via Polymer Peptide Interfusion) that can selectively bind to damaged blood vessels and activated platelets at the bleeding site. Circulating platelets are like the body’s EMTs — they are constantly surveying the body for wounds. When there is an injury to a blood vessel, the platelets get activated and attach themselves to the damaged vessel, causing a blood clot.

HAPPI binds to these activated platelets and enhances their accumulation at a bleeding site. It can be injected anywhere in the body and still make its way to the wound.

In mice models, HAPPI significantly lowered the bleeding time and bleeding volume of injuries. The researchers observed about a 99 percent reduction in bleeding time and a 97 percent reduction in blood loss. The researchers also found that for traumatic injuries, the injection of HAPPI increased the median survival rate beyond one hour — a critical goal for trauma care.

“A lot of trauma-related deaths happen within the first hour when blood loss is happening profusely and there is no intervention,” said Yongsheng Gao, a postdoctoral research associate at SEAS and the co-first author of the paper. “A key objective for first responders is to keep trauma patients alive during this so-called golden hour and in that time bring them to a hospital because once they get to the hospital, it’s a different game altogether.”

“With HAPPI, we sought to develop a safe and effective internal bandage,” said Apoorva Sarode, a former graduate student at SEAS and the co-first author of the study. “We think that the simple design and scalable synthesis process of HAPPI will facilitate its seamless scale-up and translation to larger animal models, and eventually to the patients.”

Funding from Harvard’s Blavatnik Biomedical Accelerator enabled the lab to advance and validate the technology in animal models. Going forward, the team aims to scale up the production of the materials and test it in larger animal models..

Harvard’s Office of Technology Development has protected the intellectual property associated with this project and is exploring commercialization opportunities.

The paper was co-authored by Anvay Ukidve and Zongmin Zhao from Harvard SEAS, Shihui Guo and Robert Flaumenhaft from Beth Israel Deaconess Medical Center, Anirban Sen Gupta from Case Western Reserve University, and Nikolaos Kokoroskos and Noelle Saillant from Massachusetts General Hospital. The research was supported by the National Institutes of Health under grant R01HL129179.

https://www.eurekalert.org/pub_releases/2020-07/hjap-pic073120.php

4 ways wearables may detect COVID-19 in the future

Medical researchers and tech companies have been working since the start of the pandemic to test whether wearable devices can function as a type of personal early-detection warning system to help reduce the spread of COVID-19, according to The Wall Street Journal.

Using wearable sensor data from healthy people and individuals who have COVID-19, researchers are able to compare and look for patterns in the data to then develop artificial intelligence tech that may alert other device users whose own data may begin to resemble patterns in COVID-19 patients. However, the method will only be successful after physiological data collection is further researched and at-home testing is made widely available, Eric Topol, MD, executive vice president at Scripps Research, told The Journal.

“In the months ahead people will have at their home a testing kit that will give us an answer in 15 minutes, and hopefully people will be using wearables,” Dr. Topol said. “You wouldn’t do the test unless your sensors were coming together to tell you something is going on.”

Here are four bodily measurements wearables can track that, when combined in a single device, may help with detecting COVID-19:

1. Temperature tracking. Wearable devices such as the Oura ring smart temperature reading patches can monitor and compare a user’s daily temperature readings to generate an overall average view of the individual’s health. However, more than half of people infected witch COVID-19 never develop a fever, so tracking soley temperature will not do much, according to Dr. Topol.

2. Heart rate. Heart rate and activity data may be a stronger indicator of when someone is getting sick. At Scripps Research Institute, researchers have found that resting heart-rate elevation combined with decreased physical activity and increased amounts of sleep were a clear signal for detecting the flu, and early findings from the institute’s current study on COVID-19 have indicated the same.

3. Cough. Chicago-based Northwestern University’s biomedical engineering lab created a wearable patch that rests below the user’s front base of the neck to capture temperature, heart rate, body motion, chest wall movements and respiratory sounds for coughs. For some COVID-19 patients admitted at Northwestern’s hospitals, the researchers observed coughing rates that reached an average of 100 per hour.

4. Blood oxygen. Pulse oximeters can detect when an individual has a low blood-oxygen level, which in turn could indicate a COVID-19 infection. Levels dropping into the 80 percent range may be a signal for the severity of COVID-19, however, Dr. Topol said blood-oxygen is only helpful for people who have been diagnosed with the infection to gauge the severity of the illness.

https://www.beckershospitalreview.com/digital-transformation/4-ways-wearables-may-detect-covid-19-in-the-future.html

Google says 20 states are considering contact tracing apps

Google parent Alphabet Inc. GOOGL, -3.27% GOOG, -3.16% on Friday said 20 states are “exploring” contact tracing apps for COVID-19 the company has developed with Apple Inc. AAPL, +10.46%. The technology lets app users track encounters with other people via Bluetooth and anonymously notify them if they become infected with the virus. Additionally, Google said public health authorities in more than a dozen countries and regions had launched apps using the Google-Apple tool, including Brazil, Canada, Germany, Italy, Japan, Poland, Saudi Arabia, and Switzerland.

https://www.marketwatch.com/story/google-says-20-states-are-considering-contact-tracing-contact-tracing-apps-2020-07-31

Plasma Stocks Move After Trump Roundtable On COVID-19

Plasma stocks were trading higher Friday after President Donald Trump encouraged Americans who have recovered from COVID-19 to donate their convalescent blood plasma as a treatment for the virus.

What Happened: Trump toured Red Cross headquarters wearing a mask on Thursday and met a man who had recovered from the virus donating plasma.

“If you’ve had the virus if you donate it would be a terrific thing. We really need donations of the plasma. To those that have had the virus: You’ve gotten through it and I guess that means you have something very special there,” Trump said.

Why It’s Important: Convalescent plasma has been recommended as a possible treatment for COVID-19. Patients who have had the virus and recover develop antibodies against the virus that could be used to treat those fighting COVID-19.

So far it is estimated there have been 4.4 million cases of coronavirus in the U.S., and more than 150,000 people have died from the virus in the states.

Price Action: Chanticleer Holdings SONN 41.24% shares were trading up 89.69% at $5.52 at the time of publication Friday. The stock has a 52-week high of $54.60 and a 52-week low of $2.52.

Liminal BioSciences LMNL 31.44% shares were trading down 32.75% at $16 at the time of publication. The stock has a 52-week high of $31.45 and a 52-week low of $5.25.

Kamada Ltd KMDA 1.77% shares were down 0.55% at $8.97 at last check Friday. The stock has a 52-week high of $10 and a 52-week low of $4.40.

https://www.benzinga.com/news/20/07/16873017/plasma-stocks-move-after-trump-roundtable-on-covid-19

Gilead Analysts Downplay Q2 Miss Amid Remdesivir’s COVID-19 Opportunity

Gilead Sciences, Inc. GILD 3.87% reported second-quarter revenues and earnings that trailed expectations.

The Gilead Analysts

Morgan Stanley analyst Matthew Harrison maintained an Equal-Weight rating and $79 price target for Gilead.

Raymond James analyst Steven Seedhouse maintained a Market Perform rating.

SVB Leerink analyst Geoffrey Porges has an Outperform rating and $95 price target.

Needham analyst Alan Carr has a Hold rating on Gilead.

Cantor Fitzgerald analyst Alethia Young reiterated an Overweight rating and $86 price target.

Despite Volatility, Gilead’s Q2 Was Solid: Gilead’s sales missed estimates by 3% due to destocking and slower HCV starts, reflecting temporary COVID-19 disruptions, Harrison said in a note. Among the products, Yescarta, Symtuza, Viread and Letairis beat consensus estimates, while Biktarvy, Descovy and Epclusa missed expectations.

Gilead raised its full-year revenue and non-GAAP EPS guidance.

Management said on the earnings call it expects to manufacture more than 2 million treatment courses of remdesivir by year’s end, with about 1 million to 1.5 million doses expected to be sold. The analyst estimates 1 million doses will be sold in 2020.

The company also noted that filgotinib will not have an advisory committee meeting.

“Despite some volatility, we see the quarter as solid,” Morgan Stanley said.

Notwithstanding visibility into near-term remdesivir revenues, the longer-term impact is unclear. The upcoming filgotinib PDUFA and its launch, as well as normalized remdesivir demand by the fourth quarter, are key near-term drivers of Gilead.

Raymond James Lacks Confidence In Remdesivir: Given remdesivir is over $3 billion of 2020 revenue guidance, based on 1 million to 1.5 million treatment courses at $2,500 per course, Gilead is uniquely tied to COVID-19, Seedhouse said.

The base HIV and HCV business is under considerable pressure and interruption from COVID leading to the second quarter miss, the analyst said. Recovery from the pandemic, though realigning the base business, would encumber remdesivir.

In the long run, oncology, filgotinib, and seemingly capsid inhibitor in HIV will be key drivers.

“But in the near term, we think the stock still trades on COVID and our assessment of the 1-1.5M course guidance for such a seemingly weak drug implies a disappointment could be in the cards in 4Q particularly if EU use doesn’t dramatically increase use,” the firm said in the note.

The firm remains sidelined due to its lack of confidence in remdesivir.

Remdesivir Behind The Guidance Revision: The large second-quarter bottom-lime miss came from both the top-line disappointments across multiple franchises due to COVID and generic entry, as well as increased R&D and SG&A expenses associated with remdesivir and litigation accruals, Porges said.

HCV portfolio sales fell 42% year-over-year and the HIV portfolio remained largely flat, driving product sales down by 10%, the analyst said. The guidance was raised primarily on the remdesivir opportunity.

Oncology, Gilead’s Focus Area Now And Going Forward: There are signs of recovery in Europe and parts of Asia, and a gradual recovery is likely in the U.S. in the third quarter, Carr said, citing Gilead’s management.

Most remdesivir manufactured in 2020 will be sold this year, given the pandemic trends. Key second-half events include filgotinib regulatory decision in rheumatoid arthritis in the U.S., Europe and Japan, with the management shooting for a virtual launch.

Oncology, according to the analyst, is a high priority on the business development front for the company now and going forward.

Cantor Is Positive: Cantor believes underlying base business fundamentals remain solid and will rebound over the second half of 2020 and the first half of 2021.

The company has new HIV innovations that are likely to provide a longer patent protection period beyond Biktarvy. That said, remdesivir can help Gilead to attain an attractive EPS growth profile in the interim, the analyst said.

“We remain positive on GILD here as we think the company is hitting its stride on the pipeline and the base business has strong underlying trends,” Young wrote in the note.

https://www.benzinga.com/analyst-ratings/analyst-color/20/07/16876975/gilead-analysts-downplay-q2-miss-amid-remdesivirs-covid-19-opportunity

Biotech Investors: Mark Your Calendar For August PDUFA Dates

July turned out to be a mixed month for FDA approvals. Endo International PLC’s ENDP 1.75% cellulite treatment, Osmotica Pharmaceuticals PLC’s OSMT 3.95% eye disorder drug and Jazz Pharmaceuticals PLC’s JAZZ 4.85% drug to treat excessive daytime sleepiness were among those which successfully cleared the FDA hurdle.
A few others, including Verrica Pharmaceuticals Inc VRCA 5.2% and Eagle Pharmaceuticals Inc EGRX 2.81%, are forced to wait. The regulatory agency handed down a complete response letter for Verrica’s viral skin infection treatment, while Eagle Pharma’s PDUFA date for its exertional heat stroke drug was postponed until Aug. 8 due to FDA’s reallocation of resources due to COVID-19.
Four new molecular entities, or NMEs, were approved in July, taking the total number of NME approvals for the year to 29.
Here are the key PDUFA dates scheduled for August.

GSK Seeks To Expand Use Of Triple Combo Drug To Asthma

• Company: GlaxoSmithKline plc GSK 0.17%
• Type of Application: sNDA
• Candidate: Trelegy Elypta
• Indication: asthma
• Date: Aug. 2 (estimated based on the 10-review period from the regulatory application filing date of Oct. 2)

Trelegy Elypta is a single inhaled triple therapy consisting of fluticasone furoate/umeclidinium/vilanterol) and has already been approved for chronic obstructive pulmonary disease. The company is now seeking label expansion to include asthma as an indication.
The investigational asset is jointly developed by GlaxoSmithKline and Innoviva Inc INVA 1.71%. Theravance Biopharma Inc TBPH 3.81% has an economic interest in potential future payments from GlaxoSmithKline.

Adcom Cancellation Reduces Likelihood Of DBV’s Peanut Allergy Patch Approval

• Company: DBV TECHNOLOGIE/S ADR DBVT 6.75%
• Type of Application: BLA
• Candidate: Viaskin Peanut
• Indication: Peanut allergy in children, ages 4-11 years
• Date: Aug. 5

Viaskin Peanut is DBV’s lead product candidate designed to potentially reduce the risk of life-threatening allergic reactions due to accidental exposure to peanuts. A non-invasive, once-daily, epicutaneous patch, Viaskin Peanut seeks to deliver microgram quantities of peanut antigen to activate the immune system.
The investigational immunotherapy, which has Breakthrough and Fast Track designations, was accepted for review in October 2019. The FDA communicated its intention to hold an Adcom meeting on May 15. With the agency canceling the meeting due to questions over patch’s efficacy, including the impact of patch-site adhesion, the probability of approval has reduced.

Can Second Time Prove Charm For Trevena?

• Company: Trevena Inc TRVN 4.04%
• Type of Application: NDA
• Candidate: Oleceridine
• Indication: moderate-to-severe acute pain
• Date: Aug. 7

Oliceridine is a G protein-selective mu-opioid receptor agonist in development for the management of moderate-to-severe acute pain in hospitals or other controlled clinical settings where intravenous therapy is warranted.
Trevena’s original NDA was handed down a complete response letter in November 2018, with the FDA requesting additional clinical data on QT prolongation and indicating the submitted safety database is not of adequate size for the proposed dosing.
The company resubmitted the regulatory application in February, and the FDA deemed it as a complete response and assigned a PDUFA date of Aug. 7.
“Positive physician feedback builds a strong use case of IV oliceridine,” HC Wainwright analyst Douglas Tsao said in a March note.

Eagle Pharma Awaits Decision On Heat Stroke Drug

• Company: Eagle Pharma
• Type of Application: NDA
• Candidate: Ryanodex
• Indication: exertional heat stroke, or EHS.
• Date: Aug. 8

Ryanodex, or dantrolene sodium for injectable suspension, is indicated for the treatment of malignant hyperthermia in conjunction with appropriate supportive measures. The original NDA for treating EHS was handed down a CRL in July 2017. Eagle resubmitted the application in Jan. 2020.
EHS, a severe form of heat-related illness, is characterized by core body temperature of 104° F or greater and significant neurological dysfunction, such as sudden changes in behavior, seizures or coma.
“We believe expectations for approval are low; thus, if EGRX is successful in gaining approval on or by the PDUFA date, we would expect this to be positively received given that it would provide upside not fully reflected in current estimates,” Cantor Fitzgerald said in a recent note.

Second Try For Eton’s Eye Inflammation Drug

• Company: Bausch Health Companies Inc BHC 3.13% and Eton Pharmaceuticals Inc ETON 8.44%
• Type of Application: NDA
• Candidate: EM-100
• Indication: allergic conjunctivitis.
• Date: Aug. 10

EM-100 is Eton’s preservative-free ophthalmic solution for the treatment of allergic conjunctivitis. The company has executed a commercialization deal with Bausch Health to market the ophthalmic solution. Bausch Health, which had filed a regulatory application for EM-100, received a complete response letter for the application in July 2019.
Following a resubmission, the FDA assigned a PDUFA date of Aug. 10.

Fennec Waits to Hear On Drug To Treat Chemotherapy-induced Hearing Loss

• Company: Fennec Pharmaceuticals Inc FENC 1.38%
• Type of Application: NDA
• Candidate: Pedmark
• Indication: chemotherapy-induced ototoxicity
• Date: Aug. 10

Pedmark is a unique formulation of sodium thiosulfate, and is being evaluated for the prevention of ototoxicity induced by cisplatin chemotherapy in patients one month to less than 18 years of age with localized, non-metastatic, solid tumors.
The company announced in April FDA accepted the regulatory application with priority review.
If approved, Pedmark could be the first product for the prevention of Cisplatin-induced hearing loss in children, Fennec said.

Roche Seeks Label Expansion For Asthma Biologic

• Company: Roche Holdings AG RHHBY 2.91%
• Type of Application: sBLA
• Candidate: Xolair
• Indication: Nasal polyps

Date: Q3 (estimated to be Aug. 11 based on 10 months from the filing of regulatory application)
Xolair, an antibody, has been approved in the U.S. for the treatment of moderate-to-severe persistent asthma in patients 6 years and older and chronic idiopathic urticaria in patients 12 years and older.
Roche’s Genetech unit is seeking to get approval for the additional indication of treating nasal polyps in adult patients 18 years of age and older with inadequate response to intranasal corticosteroids. If approved, Xolair would become the first antibody to help reduce the size of nasal polyps and help improve symptoms through targeting and blocking immunoglobulin E, the company said.

Gilead Awaits Nod For Rheumatoid Arthritis Drug

• Company: Gilead Sciences, Inc. GILD 3.87% and GALAPAGOS NV/S ADR GLPG 1.2%
• Type of Application: NDA
• Candidate: filgotinib
• Indication: Rheumatoid arthritis
• Date: Aug. 19 (estimated assuming a priority review)

Filgotinib, an oral, selective JAK1 inhibitor for the treatment of adults who are living with moderate-to-severe rheumatoid arthritis, is widely believed by analysts to possess blockbuster potential. Gilead had licensed the investigational asset from Galapagos.
Gilead submitted the NDA in December, along with a Priority Review voucher.

Go Or No-Go For BioMarin’s Hemophilia Gene Therapy?

• Company: BioMarin Pharmaceutical Inc. BMRN 1.57%
• Type of Application: BLA
• Candidate: Valoctocogene roxaparvove
• Indication: hemophilia A
• Date: Aug. 21

Valoctocogene roxaparvovec is BioMarin’s investigational AAV5 gene therapy for treating adults with hemophilia A. If approved, it will become the first gene therapy for any type of hemophilia.

Tricida Staring Down the Barrel Ahead Of Vevermier PDUFA Date

• Company: Tricida Inc TCDA 0.83%
• Type of Application: NDA
• Candidate: TRC 101
• Indication: metabolic acidosis in patients with chronic kidney disease
• Date: Aug. 22 
• Veverimer, codenamed TRC101, is a non-absorbed, orally-administered polymer designed to treat metabolic acidosis in patients with chronic kidney disease. Casting doubts on decision coming by the scheduled date, the company said on July 15 it received a notification from the FDA, stating that the agency has identified deficiencies that preclude discussion of labeling and post-marketing requirements/commitments at this time.
  There is little time left from now until the PDUFA date for the FDA to inform Tricida of the nature of the deficiency and for Tricida to subsequently respond, Needham analyst Alan Carr said, commenting on the FDA communication. A Complete Response Letter appears increasingly probable, he said.
  However, if the company is requested to submit additional information prior to the PDUFA date, a major amendment, triggering a three-month extension of the PDUFA date may also be a possibility.
  

  Roche Eyes SMA Drug Approval After 3-Month Delay

  • Company: Roche and PTC Therapeutics, Inc. PTCT 1.95%
  • Type of Application: NDA
  • Candidate: Risdiplam
  • Indication: spinal muscular atrophy
  • Date: Aug. 24 (expected)
  Roche is leading the clinical development of risdiplam, as part of a collaboration with the SMA Foundation and PTC. Risdiplam is an investigational, orally-administered survival motor neuron-2 splicing modifier for spinal muscular atrophy.
  Roche’s NDA was accepted for Priority Review in Decemeber, with a PDUFA date of May 24. The FDA extended the review period by three months, reasoning that it needs time to review additional data submitted by Roche in February based on its discussion with the FDA.
  

  Will Lipocine Succeed With Its Fourth Try?

  • Company: Lipocine Inc LPCN 1.99%
  • Type of Application: NDA
  • Candidate: Tlando
  • Indication: Hypogonadism
  • Date: Aug. 28
  Tlando, a novel oral prodrug of testosterone containing testosterone undecanoate, is designed to help restore normal testosterone levels in hypogonadal men.
  The investigational asset stumbled at the FDA altar three times in the past. Following Lipocine’s third resubmission, the FDA has established a PDUFA action date of Aug. 28
  

  Roche Hopes To Be Better Late Than Never

  • Company: Roche
  • Type of Application: BLA
  • Candidate: Satralizumab
  • Indication: neuromyelitis optica spectrum disorder, or NMOSD
  • Date: Aug. 29
  Satralizumab is an investigational humanized monoclonal antibody that targets the IL-6 receptor. The cytokine IL-6 is thought to be a key driver of NMOSD, triggering the inflammation cascade and leading to damage and disability.
  Roche announced FDA acceptance of the BLA Oct. 30, and assuming a standard ten-month review period, the decision is expected Aug. 29.
  Earlier this year, the Japanese drug regulatory agency approved satralizumab for treating NMOSD.
  If the approval comes through, Roche may have to face competition from two drugs already in the market, namely Alexion Pharmaceuticals, Inc.’s ALXN 2.21% Soliris and Viela Bio Inc’s VIE 2.71% Uplizna.
  

  Morphosys-Incyte Await FDA Word On Lymphoma Drug

  • Company: Incyte CorporationINCY 1.74% and Morphosys Ag MOR 2.16%
  • Type of Application: BLA
  • Candidate: Tafasitamab
  • Indication: diffuse large B cell lymphoma, or DLBCL
  • Date: Aug. 30
  Tafasitamab is an investigational humanized Fc-engineered monoclonal antibody directed against CD19. Morphosys had licensed the investigational asset from Xencor Inc XNCR 4.9% in 2010. In January, Morphosys and Incyte entered into a a collaboration and licensing agreement to commercialize tafasitamab globally.
  The FDA accepted March 2, Morphosys’ BLA, seeking approval for tafasitamab, in combination with Revlimid, as a treatment option for relapsed or refractory DLBCL. The agency set a PDUFA action date of Aug. 30.
  

  Adcom Calendar

  FDA Oncology Drug Advisory Committee will discuss Mesoblast limited’s MESO 1.68% BLA for remestemcel-L for the treatment of steroid-refractory acute graft-versus-host disease in pediatric patients.

https://www.benzinga.com/general/biotech/20/07/16855727/attention-biotech-investors-mark-your-calendar-for-august-pdufa-dates