Regulatory Focus™ > News Articles > 2021 > 6 > Recon: FDA extends shelf life of J&J vaccine; Ocugen to seek BLA for its COVID vaccine

Recon: FDA extends shelf life of J&J vaccine; Ocugen to seek BLA for its COVID vaccine

Posted 10 June 2021 | By Michael Mezher 

Recon: FDA extends shelf life of J&J vaccine; Ocugen to seek BLA for its COVID vaccine

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • US to donate 500 million Pfizer doses to poor nations (Reuters) (Politico)
  • US is in discussions with Moderna on buying Covid vaccine doses for other nations (CNBC)
  • Moderna files for US authorization to use its COVID-19 vaccine in teens (Reuters) (NYTimes)
  • FDA extends shelf life of Johnson & Johnson COVID-19 vaccine (Reuters)
  • Ocugen to file for full US approval of COVID-19 shot instead of EUA (Reuters)
  • Two members of US FDA advisory panel resign over Alzheimer's drug approval (Reuters)
  • Heart inflammation cases in young men higher than expected after mRNA vaccines: CDC (Reuters)
  • FDA plans new studies on accelerated approval disclosures in biopharma ads (Endpoints)
  • Bristol Myers' CAR-T Breyanzi busts out a win in earlier-line lymphoma, potentially cracking open an expanded market (Endpoints) (STAT)
In Focus: International
  • EU foregoes 100 million J&J vaccines, considers donating other doses – sources (Reuters)
  • AstraZeneca Vaccine Carries Slightly Higher Risk of Bleeding Disorders, Study Shows (NYTimes)
  • Taiwan says AstraZeneca COVID shot production talks fell through (Reuters)
  • India close to giving indemnity to foreign vaccine makers like Pfizer (Reuters)
  • WTO members agree to step up talks about Covid-19 intellectual property proposals (STAT)
  • Lawmakers urge EU U-turn to back vaccine patent waiver (Reuters)
  • WHO says 9 in 10 African countries to miss COVID-19 vaccination goal (Reuters)
  • BioNTech prepares expansion into Africa alongside EU (FT)
  • A Multibillion-Dollar Plan to End Polio, and Soon (NYTimes)
Coronavirus Pandemic
  • Those reports of severe Covid and deaths among the vaccinated? They’re rare, and not unexpected. (NYTimes)
  • UK, EU call for full investigation into COVID-19 origins (Reuters 1, 2)
  • COVID-19 takes center stage at U.S. primate center (Reuters)
Pharma & Biotech
  • Novartis Entresto® indicated for treatment of hypertension in China (Reuters)
  • BsUFA III Negotiations Nearly Done; Commitment Letter Being Written (Pink Sheet)
  • Will Biogen ever publish the trial results for its new Alzheimer’s drug? (Endpoints)
  • What does a clear majority of the biopharma industry think of the FDA approval of aducanumab? 'Horrifying' 'Dangerous' 'Confusing' 'Disaster' (Endpoints)
  • Novartis cuts jobs at Swiss plant as a UK facility sits in a holding pattern with 200 positions on the line — reports (Endpoints)
  • Change to Gilead Assistance Program Threatens PrEP Access, HIV Advocates Say (KHN)
  • AGC adds another major Covid-19 vaccine maker to the client list with BioNTech pact for plasmid DNA (Endpoints)
  • Beigene expands into cancer cell therapy with Shoreline pact (BioPharmaDive)
  • CDMO Vibalogics, speeding toward U.S. commercial plant, pumps $50M into viral vector capacity (Fierce)
  • A Washington CMO is doubling its manufacturing capacity, less than 5 years into its existence (Endpoints)
  • Jubilant HollisterStier plots out expansion at WA sterile injectables plant amid work on Covid-19 vaccines (Endpoints)
  • Astellas’ Xtandi bags NICE approval in prostate cancer (PharmaTimes)
  • Combined Trial Reviews To Become The Norm In UK From 2022 (Pink Sheet)
  • A Medicxi-backed startup looks to tackle treatment-resistant blood cancers, and it's going after AML first (Endpoints)
  • Versant-backed Bright Peak sets a date to bring its IL-2 into the clinic — but all eyes are on an IPO after latest mega-round drops (Endpoints)
  • Sid Mukherjee's Vor taps a CAR-T development partner to strap to its attempt at better stem cell transplants (Endpoints)
  • The Flagship train keeps chugging with its 'intersystems' player eyeing the clinic next year with 3 new drugs (Endpoints)
  • Synthekine nabs megaround in bid to edge out Merck, Sanofi in IL-2 sprint (Endpoints)
  • FDA grants accelerated approval to amivantamab-vmjw for metastatic non-small cell lung cancer (FDA)
  • FDA approves nivolumab in combination with chemotherapy for metastatic gastric cancer and esophageal adenocarcinoma (FDA)
  • The shopping spree continues: DJO acquires Switzerland’s Mathys to grow global orthopedics footprint (Fierce)
  • How To Distinguish The ‘Device Type’ For Implant Card Purposes In The EU (MedtechInsight)
  • FDA approves Medtronic’s long-lasting Vanta spinal cord stimulator (Fierce)
Government, Regulatory & Legal
  • 'The lights are no longer green': Antitrust regulators reassess pharma deals (BioPharmaDive)
  • What Tax Court's Mylan Legal Fee Ruling Means For IP Suits (Law360)
Regulatory Recon is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe.
A story's inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.


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