Regulatory Focus™ > News Articles > 2021 > 9 > Recon: EMA reviewing data on Pfizer booster shot; Roche, Adaptimmune sign $3B deal for off-the-shelf

Recon: EMA reviewing data on Pfizer booster shot; Roche, Adaptimmune sign $3B deal for off-the-shelf cell therapies

Posted 07 September 2021 | By Michael Mezher 

Recon: EMA reviewing data on Pfizer booster shot; Roche, Adaptimmune sign $3B deal for off-the-shelf cell therapies

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • Pfizer on track for US vaccine boosters, Moderna lagging, Fauci says (Reuters)
  • Israel to present COVID-19 booster shot data to FDA experts (Reuters)
  • Biden’s Covid booster shot plan mired in confusion amid regulatory hold-ups (FT)
  • Calls grow for FDA to speed authorization of kid Covid-19 vaccines (Politico)
  • White House Seeks $65 Billion for ‘Apollo’ Plan to Prepare for Future Pandemics (NYTimes)
  • Avantor bolsters COVID vaccine manufacturing with $2.9 billion Masterflex deal (Reuters)
  • FDA halts tests of BioMarin drug amid heightened focus on gene therapy safety (BioPharmaDive)
  • Drug companies say enough US states join $26 bln opioid settlement to proceed (Reuters)
  • A Big Pharma CEO Is Battling Wall Street’s Most Feared Fund (Bloomberg)
  • Congress is ready to dig into drug prices (STAT)
  • 'A missed opportunity': The biggest takeaways from the FDA's underwhelming gene therapy hearing (Endpoints)
In Focus: International
  • EU watchdog studying data on Pfizer COVID-19 vaccine booster dose (Reuters)
  • India's Hetero gets emergency use nod to make Roche's COVID-19 drug (Reuters)
  • Sinovac booster shot reverses drop in antibody activities against Delta-study (Reuters)
  • Japan picks three COVID-19 drug candidates to get research funds (Reuters)
  • Japan to purchase 150 mln doses of Takeda-produced Novavax vaccines – drugmaker (Reuters)
  • China’s Sinopharm seeks to develop its own mRNA Covid vaccine (FT)
  • Cancer giant Roche splashes into cell therapy with $3B+ Adaptimmune deal for off-the-shelf drugs (Endpoints)
  • UK unions lambast plan for major layoffs at MHRA as Brexit takes its toll (Endpoints)
Coronavirus Pandemic
  • Biden to outline strategy for controlling delta variant (The Hill)
  • CEPI warns of major hurdle to developing new Covid-19 vaccines and studying best booster approaches (STAT)
  • Denmark cancels tender for domestic coronavirus vaccine production (Reuters)
  • TGA Provisional Approval of Moderna COVID-19 vaccine to include 12-17 years age group (TGA)
  • Brazil health regulator suspends use of 12 mln Sinovac vaccine shots (Reuters)
  • Australian Novavax trial participants remain unrecognised by vaccine register (The Guardian)
  • Peru to build plant to make Sputnik V COVID-19 vaccine (Reuters)
  • Chilean health regulator approves CoronaVac use among children over age 6 (Reuters)
Pharma & Biotech
  • Two Feng Zhang lab alumni find a new CRISPR enzyme that could take a Big Gulp out of RNA — and a raft of devastating diseases (Endpoints)
  • Moving on from a major setback, Roche lines up a new Huntington's program for gene therapy sub Spark (Endpoints)
  • There's a new anti-aging upstart in town — and it's reportedly backed by Amazon billionaire Jeff Bezos (Endpoints)
  • Roche's Polivy to hit $2.4B as doctors expect 'significant switching' in newly diagnosed lymphoma: analyst (Fierce)
  • Teligent pulls 'super potent' topical lidocaine lot following failed stability tests (Fierce)
  • Food or drug? FDA blasts Flagship-backed microbiome player’s ‘non-IND’ Covid-19 trial (Endpoints)
  • GSK, J&J and Pfizer vie for $10B RSV vaccine market, with Bavarian Nordic and Moderna hot on their trail (Endpoints)
  • As tezepelumab awaits FDA decision, Amgen and AstraZeneca tout more data from the Phase III study (Endpoints)
  • Wider use of SGLT2 inhibitors for CVD recommended by NICE (Pharmafile)
  • BGI prenatal gene test under scrutiny for Chinese military links (Reuters)
  • TransMedics’ time-extending system for donor heart transplants secures FDA approval (Fierce)
  • EU MDR Relegates Future Government Concerns To Second Place in Germany (MedtechInsight)
  • Commission Launches Expert Panel Review Of High-Risk IVDs Despite No EURL Appointments Yet (MedtechInsight)
  • What Does the EMA Involvement In Expert Panels Mean For Future Device Oversight? (MedtechInsight)
Government, Regulatory & Legal
  • Theranos founder's defense may turn on state of mind, experts say (Reuters)
  • Teva Drops Claim That Rival Slowed Generic Development (Law360)
  • Bristol Myers, Pfizer score another win in their Eliquis patent defense, protecting the blockbuster until 2028 (Fierce)
  • The FDA has just 3 days to decide how to regulate 6.5 million e-cigarette products. But what if it blows past the deadline? (STAT) (Politico)
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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