Pfizer pushes India for ‘expedited’ vaccine approval

 Pfizer is pushing India’s government for an “expedited approval pathway” for its COVID-19 vaccine — and announced a donation of medicines worth more than $70 million amid a catastrophic surge in infections in the country. 

“Unfortunately, our vaccine is not registered in India although our application was submitted months ago,” CEO Albert Bourla wrote a letter to his colleagues in India, which he shared on LinkedIn Monday. “We are currently discussing with the Indian government an expedited approval pathway to make our Pfizer-BioNTech vaccine available for use in the country.”

He also said that Pfizer employees in the US, Europe and Asia are working to ship medications that India’s government has approved as part of its COVID treatment protocol. 

People line up to get the COVID-19 vaccine outside a school-turned-vaccination centre in New Delhi on May 3, 2021.

JEWEL SAMAD/AFP via Getty Images

“These medicines, valued at more than $70 million, will be made available immediately, and we will work closely with the government and our NGO partners to get them to where they are needed most,” he said. 

People waiting for their second dose of the COVID-19 vaccine in in Siliguri, India on May 3, 2021.

DIPTENDU DUTTA/AFP via Getty Images

The news comes as India recorded 368,147 new COVID-19 cases and 3,417 new deaths on Monday. 

A COVID-19 testing site in India, where a massive surge of infections has hit the country recently.

EWEL SAMAD/AFP via Getty Images

Since the start of the pandemic, 19.9 million cases of the virus have been reported in India — behind only the US, which has counted more than 32.4 million. 

Workers load 300 tons of medical aid to be flown in a three-flight cargo aircraft convoy directly to destinations in India, at Qatar’s Hamad International Airport on May 3, 2021.

KARIM JAAFAR/AFP via Getty Images

More than 218,000 people in India have died of the virus, according to the health ministry.

However, experts believe both figures are significant undercounts. 

India recorded 368,147 new COVID-19 cases and 3,417 new deaths on May 3, 2021.

REUTERS/Amit Dave

Leaders of 13 opposition parties have urged India’s government to launch a free vaccination drive and make sure that all hospitals receive an uninterrupted flow of oxygen. 

A health worker gives a man the COVID-19 vaccine on May 3, 2021 in India.

EWEL SAMAD/AFP via Getty Images

Several hospital authorities over the weekend sought court intervention over oxygen supplies in New Delhi, which has extended its lockdown by a week to contain the surge of infections. 

https://nypost.com/2021/05/03/pfizer-pushes-india-for-expedited-vaccine-approval/

Amphastar Receives FDA Approval for Morphine Sulfate Injection

 Amphastar Pharmaceuticals, Inc. (NASDAQ: AMPH) announced that the U.S. Food and Drug Administration (“FDA”) approved the Company’s Abbreviated New Drug Application (“ANDA”) for Morphine Sulfate injection 1mg/mL in the 30mL Pump-Jet® Prefilled Syringe System. It is indicated for the management of pain severe enough to require use of an opioid analgesic by Patient-Controlled Analgesia (PCA), only for use with a compatible Alaris® infusion device, and for which alternative treatments are inadequate. For the past 30 years, the company has sold and marketed the product under the “grandfather” exception to the FDA’s “Prescription Drug Wrap-Up” program. Net revenues for the Company’s Morphine injection for the year ended December 31, 2020, were $2.3 million.

https://finance.yahoo.com/news/amphastar-pharmaceuticals-receives-fda-approval-100000419.html

Clearside Resubmits Application for Macular Edema Treatment

 Clearside Biomedical, Inc. (Nasdaq: CLSD), a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases, announced today the resubmission of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for XIPERETM (triamcinolone acetonide suprachoroidal injectable suspension) for the treatment of macular edema associated with uveitis.

Clearside’s resubmission is a full and complete response to all of the items identified in the Complete Response Letter (CRL) received from the FDA on October 18, 2019. Clearside believes this application will be considered a Class 2 resubmission, with a targeted six-month review timeline under the Prescription Drug User Fee Act.

https://finance.yahoo.com/news/clearside-biomedical-announces-resubmission-drug-110500856.html

Passage Bio, Partner on Counseling, Testing for Form of Early Onset Dementia

 

• No-cost genetic screening and counseling program aimed at identifying FTD patients who have certain inherited genetic mutations to guide early treatment intervention and awareness of clinical trials
  

• Passage Bio is evaluating gene therapy candidate, PBFT02, for treatment of FTD with granulin mutations

 Passage Bio, Inc. (NASDAQ: PASG), a clinical-stage genetic medicines company focused on developing transformative therapies for rare, monogenic central nervous system disorders; and InformedDNA, the nation’s leading genetics services organization, today announced a collaboration to provide no-cost genetic counseling and testing for adults who have been diagnosed by their physicians with Frontotemporal Dementia (FTD).

The testing program will facilitate identification of patients with FTD with certain inherited genetic mutations, providing an important step for early and precise treatment intervention, as well as supporting clinical trial recruitment and enrollment. FTD is a debilitating form of early onset dementia that currently has no approved disease-modifying therapies. Approximately 30 percent of all FTD is hereditary and most commonly involves a mutation of the granulin (GRN), C9orf72 or MAPT genes – all of which are tested for in this program.

“FTD is a life-threatening condition that progresses rapidly and has an average survival of eight years after onset of symptoms, so it is critical that patients are identified as early as possible to achieve the best outcomes for them,” said Bruce Goldsmith, Ph.D., president and chief executive officer of Passage Bio. “By partnering with InformedDNA, we are able to offer patients with FTD an option to potentially identify whether there is an inherited genetic mutation causing their disease. This will enable clinicians to intervene sooner with an appropriate treatment approach for their specific form of the disorder. We believe this collaboration can serve as a valuable resource for the FTD community, allowing for earlier treatment or participation in clinical trials aimed at finding innovative treatment options.”

https://finance.yahoo.com/news/passage-bio-partners-informeddna-offer-110000718.html

Intra-Cellular: FDA Accepts Application for Bipolar Therapy

  Intra-Cellular Therapies, Inc. (Nasdaq: ITCI), a biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system (CNS) disorders, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review its supplemental New Drug Applications (sNDAs) for lumateperone, an investigational agent for the treatment of depressive episodes associated with bipolar I or II disorder (bipolar depression) as monotherapy and as adjunctive therapy with lithium or valproate. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of December 17, 2021 for the applications. If approved, CAPLYTA has the potential to be an important medicine for a broad group of patients suffering from these highly prevalent, chronic complex conditions.

Two positive Phase 3 global placebo-controlled bipolar depression studies, Study 402 and Study 404, form the basis of the CAPLYTA sNDAs for the treatment of bipolar depression. In these clinical trials, lumateperone 42 mg demonstrated a favorable tolerability and safety profile consistent with findings in all of our previous studies in schizophrenia. The most commonly reported adverse events (defined as a rate greater than or equal to 5% and at least twice the rate of placebo) were somnolence, dizziness and nausea. Importantly, the rates of akathisia, restlessness and extrapyramidal symptoms were low and similar to placebo.

“We are pleased that the FDA has accepted our sNDAs for review and we look forward to working with the FDA during the review process,” said Dr. Sharon Mates, Chairman and CEO of Intra-Cellular Therapies. “We believe CAPLYTA has the potential to be an important option for patients in the treatment of bipolar depression.”

https://finance.yahoo.com/news/intra-cellular-therapies-announces-fda-113000095.html

XOMA Earns Milestone from Janssen in Phase 3 Development

 XOMA Corporation (Nasdaq: XOMA) (“XOMA” or the “Company”) today announced it has earned a $0.5 million milestone from Janssen Biotech, Inc. (Janssen), as a result of the first patient dosed in a Phase 3 clinical trial evaluating one of Janssen’s biologic assets.

“Since 2017, our milestone and royalty portfolio has seen 27 advancements from one phase of development to the next. Each advance increases the potential value of the asset, as it moves closer to a possible regulatory approval and market launch. Cetrelimab is the second molecule to advance to Phase 3 development since we pivoted to become a biotech royalty aggregator in 2017,” stated Jim Neal, Chief Executive Officer at XOMA. “We congratulate Janssen on reaching this important step and wish them continued success in their clinical development endeavors.”

Under the terms of the agreement with Janssen, XOMA has the potential to receive additional regulatory milestone payments should Janssen achieve marketing approval, and upon commercialization, the Company will receive a royalty on future commercial sales. Should Janssen expand its late-stage development activities beyond the targeted indication, XOMA could receive additional milestone economics.

https://finance.yahoo.com/news/xoma-earns-milestone-first-patient-113000976.html

Alnylam: Positive Early Results on Clinical Outcome from Phase 3 Study

 OXLUMO Demonstrated Improvements in Nephrocalcinosis in Patients with Primary Hyperoxaluria Type 1 After 12 Months of Treatment –

Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, announced today positive early results on clinical outcome measures from the 12-month analysis of ILLUMINATE-A Phase 3 study of OXLUMO® (lumasiran), an RNAi therapeutic targeting hydroxyacid oxidase 1 (HAO1) – the gene encoding glycolate oxidase (GO) – for the treatment of primary hyperoxaluria type 1 (PH1). These data were presented at the American Society of Pediatric Nephrology (ASPN)/Pediatric Academic Societies (PAS) virtual meeting being held on April 30–May 4, 2021.

As previously reported, treatment with OXLUMO significantly reduced urinary oxalate levels in infants1, children1,2 and adults2 with PH1 in the ILLUMINATE-A and ILLUMINATE-B studies. OXLUMO also demonstrated an acceptable safety profile across age groups, with injection site reactions as the most common drug-related adverse reaction. New results from ILLUMINATE-A showed that treatment with OXLUMO for 12 months was associated with evidence of improvements in nephrocalcinosis in one or both kidneys, relative to baseline.

https://finance.yahoo.com/news/alnylam-announces-positive-early-results-110000887.html