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Recon: Catch up on the news you missed over the holidays

Posted 04 January 2021 | By Michael Mezher 

Recon: Catch up on the news you missed over the holidays

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • Drugmakers to hike prices for 2021 as pandemic, political pressure put revenues at risk (Reuters) (BioPharmaDive)
  • Pfizer and BioNTech to offer COVID vaccine to volunteers who got placebo (Reuters)
  • US distributes over 13.07M doses of COVID-19 vaccines; 4.2M administered -CDC (Reuters)
  • US may cut some Moderna vaccine doses in half to speed rollout, official says (Reuters) (Politico)
  • Moderna raises 2021 vaccine output forecast to at least 600 million doses (Reuters)
  • Warp Speed chief: U.S. won’t get AstraZeneca vaccine until April (Politico) (Reuters)
  • Dialysis clinics provide new path for delivery of stockpiled COVID-19 antibody drugs in US (Reuters)
  • US appeals court upholds Trump health care price disclosure rule (Reuters)
  • Novavax starts late-stage trial of COVID-19 vaccine in United States (Reuters)
  • Bristol-Myers Derivative Is Now Worthless as Key Deadline Passes (Bloomberg) (BioPharmaDive)
  • Former Walmart Pharmacists Say Company Ignored Red Flags As Opioid Sales Boomed (NPR)
In Focus: International
  • EU seeks more doses of Pfizer vaccine as Germany outlines earlier deal (Reuters)
  • EU drugs agency meeting to discuss Moderna COVID-19 vaccine (Reuters)
  • AstraZeneca vaccine not ready for quick European approval, watchdog official says (Reuters 1, 2) (EMA)
  • Britain takes a gamble with Covid-19 vaccines, upping the stakes for the rest of us (STAT)
  • Britain will allow mixing of COVID-19 vaccines on rare occasions (Reuters)
  • China gives its first COVID-19 vaccine approval to Sinopharm (Reuters)
  • India's drugs experts approve AstraZeneca, local COVID vaccines (Reuters)
  • India's approval of homegrown vaccine criticised over lack of data (Reuters)
  • AP Interview: India bars virus vaccine maker from exporting (AP)
  • Russia approves Sputnik V COVID-19 vaccine for people over 60: media (Reuters)
  • WHO emergency COVID-19 vaccine listing aims to lift access in poor countries (Reuters) (WHO)
  • In Canada, shippers race to move cancer treatments as COVID-19 grounds flights (Reuters)
  • Drugmakers agree to halve prices to get on China state insurance list (Reuters)
  • Italy’s Angelini to buy Swiss biotech group for $1bn (FT)
Coronavirus Pandemic
  • Biden picks 3 coordinators for Covid-19 response (Politico)
  • Vaccine makers race to secure supply chains (FT)
  • UK scientists trial drug to prevent infection that leads to Covid (The Guardian)
  • Regeneron's COVID-19 antibody therapy shows promise in hospitalized patients (Reuters)
  • Germany mulls delaying second COVID-19 vaccine shot, Denmark approves delay (Reuters)
  • Russia ready to trial combined AstraZeneca, Sputnik V vaccine in Ukraine (Reuters)
  • Lonza gets Swiss OK to start Moderna vaccine production (Reuters)
  • Sweden's Recipharm to help make Moderna's COVID-19 vaccine outside U.S (Reuters)
  • Netherlands brings forward start of COVID-19 vaccination campaign (Reuters)
  • Inovio partners with Advaccine to make and sell COVID-19 vaccine in China (Reuters)
  • China's Fosun plans plant to make BioNTech's COVID-19 vaccine -Caixin (Reuters)
  • Vietnam to buy AstraZeneca vaccine, in talks with other producers (Reuters)
  • Philippines gives green light to trials of Janssen's COVID-19 vaccine (Reuters)
  • Moderna to supply 40 million doses of COVID-19 vaccine to South Korea (Reuters)
  • Lebanon secures COVID-19 vaccines for 20% of its citizens - health minister (Reuters)
  • Mexico says approval of AstraZeneca vaccine 'imminent' after UK go-ahead (Reuters)
  • AstraZeneca tells Chile to wrap up vaccine trial recruitment (Reuters)
  • El Salvador greenlights AstraZeneca, Oxford University COVID-19 vaccine (Reuters)
  • Colombia reaches deal with J&J for 9 million vaccine doses (Reuters)
  • Russia's Sputnik vaccine applies for Phase 3 study in Brazil (Reuters)
  • Pfizer and Brazil regulator in talks to speed up emergency vaccine approval (Reuters)
  • Brazil's Fiocruz to seek emergency use of British COVID-19 vaccine (Reuters)
  • Brazil to import 2 million AstraZeneca vaccine doses, not yet approved for use (Reuters)
  • Jordan secures 3 million doses of COVID-19 vaccine - prime minister (Reuters)
  • Germany's GNA Biosolutions offers new quick coronavirus test (Reuters)
Pharma & Biotech
  • 3 biotech trends to watch in 2021 (STAT)
  • It was the best of all possible worlds in the worst of all times for biotech in 2020. What comes now? (Endpoints)
  • 2020’s NDA list is packed with commercial firsts — from historic to haphazard. Have we reached a tipping point? (Endpoints)
  • The biotech 2021 preview, from M&A to gene therapy and more (STAT)
  • The Biotech Paradox of 2020: A Year In Review (LifeSciVC)
  • US FDA 2020 Novel Approval Count Rises To 53 At CDER, Plus 5 New CBER Biologics (Pink Sheet)
  • Pharma Breathes Sigh Of Relief Over Post-Brexit Trade Deal (Pink Sheet)
  • EU-UK Trade Deal Allows For Mutual Recognition Of GMP Inspections (Pink Sheet)
  • UK Regulator Vaunts A 'New Era' In Drug Approvals (Pink Sheet)
  • FDA lifts clinical hold on Audentes' gene therapy program after three patient deaths triggered alarms (Endpoints)
  • Pfizer, Opko's growth hormone med en route to October FDA decision (Fierce)
  • Slammed with PhII flop for lead drug, Calithera lays off a third of its staffers (Endpoints)
  • Alkermes sees swift turnaround for rejected schizophrenia med as FDA accepts resubmission (Fierce)
  • USFDA informs Biocon Biologics, Mylan of deferred action on Avastin biosimilar license application (Economic Times)
  • With pipeline setbacks mounting, United snares priority voucher for inhaled formulation of PAH med Tyvaso (Endpoints)
  • Bristol Myers Squibb walks on Opdivo's FDA nod for small-cell lung cancer after middling OS data couldn't back approval (Endpoints)
  • Pfizer’s Lorbrena scores US priority review (PharmaTimes)
  • CRUK scientists develop drug that targets KRAS pathways (PharmaTimes)
  • Janssen files EGFR-targeting antibody amivantamab with EMA (PharmaTimes)
  • Pharma heavyweight Pfizer stepping into the prostate cancer ring with AbbVie after inking a $4.2B alliance with Myovant (Endpoints)
  • Lynn Seely hits the exit as Myovant graduates to commercial space — handing the reins to Amgen vet (Endpoints)
  • Oncorus plots early-stage plant in Boston area as it walks I-O candidate through the clinic (Endpoints)
  • Charles River bags antibody discovery-focused Distribution Bio for $104M, signaling return to pre-pandemic buyout spree (Endpoints)
  • After a ‘breakthrough’ beginning to 2020, little Aprea gets crushed by a PhIII failure (Endpoints)
  • Fast-expanding Shanghai Pharma breaks ground on $1.8B biotech park focused on next-gen R&D, antibody production (Endpoints)
  • In quick start to new year's M&A, Arvelle Therapeutics hands reins to Angelini as it nears EU approval for cenobamate (Endpoints)
  • FDA Approves First Generic of Drug Used to Treat Severe Hypoglycemia (FDA)
  • FDA Announces OTC Monograph Drug User Fees for Manufacturers for FY2021 (FDA Law Blog) (FDA)
  • The top medtech deals of 2020 (and one that got away) (MedtechDive)
  • Brexit deal creates regulatory barriers to UK-EU medical device trade (MedtechDive) (MedtechInsight)
  • Senseonics' 180-day Eversense glucose monitor delayed at FDA by COVID-19 pandemic (Fierce)
  • Ra Medical settles DOJ false claims investigations (Fierce)
  • Hologic starts spending its COVID-19 testing windfall, with $64M Somatex breast cancer biopsy acquisition (Fierce)
  • Product Labeling for Laparoscopic Power Morcellators; Guidance for Industry and Food and Drug Administration Staff; Availability (FDA)
Government, Regulatory & Legal
  • Seniors Face Crushing Drug Costs as Congress Stalls on Capping Medicare Out-Of-Pockets (KHN)
  • Federal Courts in Maryland and California Block Trump Administration’s Most Favored Nation Drug Pricing Rule on Procedural Grounds (FDA Law Blog)
  • New ASP Reporting Requirement for Manufacturers without a Medicaid Drug Rebate Agreement (FDA Law Blog)
  • Eli Lilly & Co. v. Apotex, Inc. (Fed. Cir. 2020) (Patent Docs)
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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