Regulatory Focus™ > News Articles > 2021 > 2 > Recon: FDA issues EUA for Lilly antibody combo; Federal court tosses ‘skinny labeling’ decision

Recon: FDA issues EUA for Lilly antibody combo; Federal court tosses ‘skinny labeling’ decision

Posted 10 February 2021 | By Michael Mezher 

Recon: FDA issues EUA for Lilly antibody combo; Federal court tosses ‘skinny labeling’ decision

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • Gilead’s Galapagos deal falls apart, a black mark for CEO O’Day (STAT) (Endpoints) (Reuters)
  • Eli Lilly's antibody combination receives FDA EUA for COVID-19 (Reuters) (Endpoints) (FDA)
  • FDA panel admonishes Merck with a gentle — and rare — slapdown for rushing its pitch on an accelerated OK for adjuvant Keytruda in TNBC (Endpoints) (Pink Sheet)
  • To the delight of generic drug makers, federal appeals court tosses controversial ‘skinny labeling’ decision (STAT) (Law360)
  • America’s addiction crisis, compounded by Covid-19, requires immediate action to save lives (STAT) (The Hill)
  • Lawmakers urge Biden to back opioid-treatment measure (Washington Post)
  • House Democrats slip drug pricing proposal into Covid-19 relief bill (STAT) (The Hill)
  • Biden administration to begin shipping vaccines to health centers (Politico)
In Focus: International
  • EU's von der Leyen admits to failings in vaccine fight (Reuters)
  • EU regulator says Russia yet to submit COVID-19 vaccine application (Reuters)
  • EMA expected to approve J&J vaccine by March - CEO of Janssen Italy to paper (Reuters)
  • WHO recommends use of Oxford/AstraZeneca vaccine for all adults (FT)
  • Drug maker will slash prices on cancer medicines to end price gouging probe in Europe (STAT)
  • SoftBank to Make $900 Million Investment in Pacific Biosciences (WSJ) (Endpoints)
  • Teva Pharm in talks to co-produce COVID-19 vaccines, CEO says (Reuters)
  • South Korea to approve AstraZeneca as first COVID-19 vaccine, including for elderly (Reuters)
  • India's Biological E looking to make 600 million J&J vaccine shots a year (Reuters)
  • Common asthma drug cuts COVID-19 hospitalization risk, recovery time - Oxford study (Reuters)
Coronavirus Pandemic
  • CDC: Double-masking helps reduce exposure to the coronavirus (Politico)
  • J&J CEO says people may need annual Covid vaccine shots for the next several years (CNBC)
  • WHO's Wuhan probe ends, U.S.-China bickering over COVID continues (Reuters)
  • US to scrutinize WHO report that rules out COVID-19 came from Chinese lab (Reuters)
  • New Zealand to inoculate high-risk people first as COVID-19 vaccine gets full approval (Reuters)
  • J&J applies for COVID-19 vaccine emergency authorisation from South Africa (Reuters)
  • NIH trial of AZ's long-acting COVID-19 antibody launches in the US (PMLive)
  • Germany's IDT to help make AstraZeneca's COVID-19 vaccine (Reuters)
  • Inovio expects to begin late-stage COVID-19 vaccine study in second quarter (Reuters)
  • Pfizer could directly deliver COVID-19 shot to S.Africa vaccination points (Reuters)
  • Moderna to supply COVID-19 vaccine to Taiwan and Colombia (Reuters)
  • China's CanSinoBIO says Mexico approves COVID-19 vaccine for emergency use (Reuters)
  • eSwatini will not use AstraZeneca vaccine after S.Africa trial data (Reuters)
Pharma & Biotech
  • Complex Generics: US FDA, Sponsors View Roadblocks Very Differently (Pink Sheet)
  • Push and pull: funding drugs to be used only sparingly (FT)
  • How the UK boosted its vaccine manufacturing capacity (FT)
  • Accelerated Approvals Could Be Improved By Focusing On Benefit/Risk, Making Withdrawal Easier (Pink Sheet)
  • French API maker Seqens primed for sale to the tune of $2.4B: report (Fiercev)
  • AbbVie exploring how CRISPR gene editing can improve cell therapies (BioPharmaDive)
  • Latest Improvements in FDA’s Inactive Ingredient Database Include Change Log and Use of Maximum Daily Exposure (IPQ)
  • Janssen Wins EU Fast-Track Status For CAR-T Therapy Cilta-Cel (Pink Sheet)
  • AbbVie adds to the Botox war chest with a 12th FDA approval — but competition is fast approaching (Endpoints)
  • AbbVie taps Jennifer Doudna startup for licensing deal worth up to $300M for 2 'off-the-shelf' CRISPR-edited CAR-Ts (Endpoints) (Fierce)
  • ASCO GU: Bristol Myers touts first-in-class Opdivo win in muscle-invasive bladder cancer (Fierce)
  • With Libtayo's second approval, Regeneron digs deeper into PD-1 dermato-oncology niche (Endpoints) (Fierce)
  • AstraZeneca partners to set up Hong Kong biotech incubator (Fierce)
  • On the hunt for a better antibody, BigHat Biosciences debuts with $19M Series A to scale its 'wet lab' AI platform (Endpoints)
  • Firm that makes COVID-19 treatment remdesivir to add 275 jobs in Wake County (News Observer)
  • The Broad Institute’s new leader wants to ‘double down’ on biology (STAT)
  • Sanofi Grows Clinical Trials During Pandemic With Use Of Inhouse Clinical Supply Chain (Pink Sheet)
  • Mirati and MD Anderson team up on KRAS; Sanofi inks deal with a Harvard spinout for oral biologics (Endpoints)
  • Eli Casdin and Icahn protégé find a home for their $450M SPAC, merging with Sema4 (Endpoints)
  • 'Industrializing the production of cells': Another iPSC player joins the quest for off-the-shelf cell therapies (Endpoints)
  • With a roster of gene therapy vets, Forbion makes a bet on 'relatively empty space' of vectorized antibodies (Endpoints)
  • Celltrion begins Phase 3 trial of aflibercept biosimilar (Big Molecule Watch)
  • Heart disease devices lead latest batch of FDA breakthrough nods (MedtechDive)
  • ‘These numbers are incredibly important’: Doctors and lawmakers call on FDA to address racial disparities in pulse oximeters (STAT)
  • Using Ventilator Splitters During the COVID-19 Pandemic - Letter to Health Care Providers (FDA)
  • Report of Quidel-Qiagen tie-up makes 'no sense,' Wall Street analysts say (MedtechDive)
  • MedLumics nets $21.8M to test its optically guided heart ablation catheter (Fierce)
  • Cost Pressures Prompt Possible Device Fee Increases In Australia (MedtechInsight)
Government, Regulatory & Legal
  • Celgene Sues Dr. Reddy's To Block Cancer Drug Generic (Law360)
  • Pfizer Says It's Immune From Vaccine Testing IP Claims (Law360)
  • 3rd Circ. Won't Give Fresenius Another Look At Drug Claim (Law360)
  • AbbVie, Others Move To End Generic Bystolic Antitrust Claims (Law360)
  • Teva-Centric Price-Fix Case Likely To Lose Bellwether Status (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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