rf-fullcolor.png

 

March 3, 2021
by Michael Mezher

Recon: Merck to conduct new trial of OncoImmune COVID drug; NIH halts convalescent plasma trial

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • Biden says will have enough COVID-19 vaccine for every U.S. adult by May (Reuters) (NYTimes)
  • Biden calls on states to prioritize vaccinations for teachers (Reuters)
  • White House using Defense Production Act to equip Merck plants for J&J vaccine (Reuters) (NPR) (Fierce)
  • White House taps insurers to boost vaccinations among vulnerable communities (Politico)
  • Vir, GSK to halt enrollment in US COVID-19 antibody trial sub-study (Reuters)
  • Merck Prepares New Trial of Covid Drug Gained in Acquisition (Bloomberg) (Fierce)
  • NIH halts trial of Covid plasma treatment after researchers found no benefit (CNBC)
  • Lilly drug regrows hair in autoimmune disease study, but safety questions linger (BioPharmaDive)
  • Senate panel deadlocks on advancing Biden's pick for health secretary (Politico)
  • Senate trims parts of Biden's $1.9 trillion coronavirus relief bill before votes (Reuters)
In Focus: International
  • EU targets vaccine production capacity of 2-3 billion doses/year by end-2021 paper (Reuters)
  • EU regulator not budging on vaccine dosage as states scramble for shots (Reuters)
  • World Bank readies COVID-19 vaccine funds for around 30 African countries (Reuters)
  • Poland strikes deal to produce Novavax COVID-19 vaccine (Reuters)
  • Bharat Biotech's COVID-19 shot 81% effective, Indian firm's interim data shows (Reuters)
  • UK to receive 10 million AstraZeneca COVID-19 vaccine doses from India's Serum Institute (Reuters)
  • Cuba starts final-stage trials of two homegrown Covid vaccines (FT)
  • Takeda takes full control of drug for rare epilepsies (BioPharmaDive) (STAT)
Coronavirus Pandemic
  • A Covid-19 Vaccine Without a Needle? These Firms Are On the Case (WSJ)
  • Second UK trial to study gout drug colchicine as COVID-19 treatment (Reuters)
  • Italy could produce bulk vaccines in 4-6 months: ministry (Reuters)
  • International megatrial of coronavirus treatments is at a standstill (Science)
  • Unredacted Pfizer contract with Dominican Republic, shows broad indemnity provisions for COVID-19 vaccine sales (KEI)
  • Citing lack of data, Polish health minister does not recommend Chinese shot (Reuters)
  • Turkish study revises down Sinovac COVID-19 vaccine efficacy to 83.5% (Reuters)
  • Sinovac eyes two billion doses in annual capacity of virus vaccine by June (Reuters)
  • Senegal receives its first AstraZeneca vaccines under COVAX (Reuters)
  • South African scientists find antibodies from variant may offer cross-protection (Reuters)
  • Hungary to extend AstraZeneca jabs to people over 60, official says (Reuters)
  • Palestinian COVID-19 vaccine rollout under fire over doses for VIPs (Reuters)
Pharma & Biotech
  • A closely watched schizophrenia drug fails key test (BioPharmaDive)
  • Sarepta Charges Ahead With DMD Gene Therapy Despite Setback (Scrip)
  • US FDA’s Big Transition: Not The Commissioner – The Drug Center (Pink Sheet)
  • The 2021 top 100 biopharma investors: As the pandemic hit and IPOs boomed, VCs swung into action like never before (Endpoints)
  • Camurus, Accord, Swedish Orphan Biovitrum (Sobi), Strides Pharma, Boehringer Ingelheim, Vifor Pharma, GlaxoSmithKline and Sintetica named in advertisements for breaches of the ABPI Code (PMCPA)
  • Sotagliflozin Hail Mary? Lexicon Seeks Opportunity For Formal Hearing On FDA Intent To Deny Approval (Pink Sheet)
  • Arena's pain drug fails phase 2b, prompting review of 'strategic options' (Fierce)
  • Arbor Emphasizes Risks Of Its Own Product In Suit Against US FDA To Block Nymalize Generics (Pink Sheet)
  • AstraZeneca/FibroGen’s Roxadustat Comparison To ESAs In Anemia May By Clarified At FDA Advisory Cmte (Pink Sheet) (Fierce)
  • Swiss CDMO Celonic finds a home at Novartis' Stein hub, plans to add 250 new jobs centered on next-gen drugs (Endpoints)
  • Gilead cuts jobs in California, moving some to new North Carolina business center (Fierce)
  • NICE backs NHS use of Lilly’s Olumiant in eczema (PharmaTimes)
  • Doudna-founded biotech Caribou raises fresh funds to fuel gene editing pipeline (BioPharmaDive)
  • World Pharmacopoeias support public health during COVID-19 pandemic (WHO)
  • IPM’s New Drug Application for Dapivirine Vaginal Ring to Reduce HIV Risk in Women Accepted for Filing by US Food and Drug Administration (Press)
  • Fresh off $1B+ Merck deal, Janux locks down first private fundraise for its T cell engagers (Endpoints)
  • Sofinnova Partners stays focused on late-stage deals with a new, $540M crossover fund (Endpoints)
  • Presage teams with Merck on its Phase 0 testing; KemPharm ADHD drug wins approval in children aged 6 and up (Endpoints)
  • As allogeneic cell therapy approaches flourish, Century loads up $160M to scale iPSC platform for CAR-T, CAR-NK (Endpoints)
  • Khosla joins bet on unconventional startup looking to send drug delivering robots into the brain (Endpoints)
  • United axes PAH program Trevyent, once bought for cheap in acquisition of a rival, after FDA feedback (Endpoints)
Medtech
  • UK startup develops gyroscope glove to ease tremors for those with Parkinson's (Reuters)
  • Asensus Surgical scores general surgery clearance for its Senhance robot (Fierce)
  • UK’s NICE Backs Two Microsphere Products For Liver Cancer But Says No To Another (MedtechInsight)
  • Boston Scientific puts up $1B in cash to buy Lumenis surgical line from private equity (MedtechDive)
  • Cook Medical lands FDA breakthrough status in latest round of cardio-themed nods (MedtechDive)
  • Agilent strikes $550M Resolution buyout to muscle in on liquid biopsy space (MedtechDive)
  • Panel Back On Track For TransMedics’ Heart Device After Missing A Few Beats (MedtechInsight)
  • FDA grants De Novo classification to Fifth Eye's continuous hemodynamic status monitoring tool (mobihealthnews)
Government, Regulatory & Legal
  • Supreme Court Argument on Arthrex and the Constitutionality of IPRs (Big Molecule Watch)
  • U.S. v. Arthrex: Supreme Court Oral Argument (Patent Docs 1, 2)
  • J&J, Bard $83M Pelvic Mesh Verdicts Overturned (Law360)
  • J&J Urges High Court To Nix $2.1B Talc Verdict (Law360)
  • AstraZeneca wins US court ruling on Symbicort patent claims (Pharmafile)
  • Teva, Mylan Back Plan For New Bellwether In Price-Fix MDL (Law360)
  • Hospital Groups Want To Join Fight Over Drug Discount Rule (Law360)
  • Supreme Court Urged To Rein In Use Of Assignor Estoppel (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.
×

Welcome to the new RAPS Digital Experience

We have completed our migration to a new platform and are pleased to introduce the updated site.

What to expect: If you have an existing login, please RESET YOUR PASSWORD before signing in. After you log in for the first time, you will be prompted to confirm your profile preferences, which will be used to personalize content.

We encourage you to explore the new website and visit your updated My RAPS page. If you need assistance, please review our FAQ page.

We welcome your feedback. Please let us know how we can continue to improve your experience.