Recon: Blueprint's $250M preclinical buy; WHO, CDC, Biden react to Omicron variant

ReconRecon | 29 November 2021 |  By 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • Biden says omicron variant is cause for concern but not panic (NPR)
  • CDC Statement on B.1.1.529 (Omicron variant) (CDC)
  • Pfizer boosts Paxlovid manufacturing capacity as Merck’s rival COVID pill hits surprise efficacy setback (Fierce)
  • Opinion: Becerra needs to open up to the press (AHCJ)
  • Opinion: Will Moderna Ever Learn to Share? (MedPage Today)
  • Who Would Be the Best FDA Commissioner for Biotech Investors? (Nasdaq/Motley Fool)
  • The overlooked public health issue that could make or break Biden’s new drug regulator (Politico)
  • November 30, 2021: Antimicrobial Drugs Advisory Committee Meeting Announcement (FDA) (CNBC)
In Focus: International
  • Role and future of European Medicines Agency with Emer Cooke (ENVI)
  • S.Africa's COVID-19 cases could triple this week, expert says (Reuters)
  • 13 omicron cases detected in Portuguese pro soccer team (The Hill)
  • Switzerland, Scotland report omicron cases (The Hill)
  • Merkel’s push for German lockdown reportedly blocked as death toll passes 100,000 (CNBC)
  • Comirnaty COVID-19 vaccine: EMA recommends approval for children aged 5 to 11 (EMA)
  • MHRA statement on expansion of the COVID-19 vaccination booster programme (MHRA)
  • The EU is planning a 9-month expiration date on its Covid vaccine passports (CNBC)
  • A different type of COVID-19 vaccine is about to roll out around the world (NPR)
Coronavirus Pandemic
  • The World Health Organization warns of very high risk posed by the omicron variant (NPR) (CNBC)
  • New Omicron Covid-19 Coronavirus Variant Leads U.S., Others To Impose Travel Restrictions (Forbes)
  • As World Shuts Borders to Stop Omicron, Japan Offers a Cautionary Tale (NYT)
  • Omicron variant not a problem for COVID-19 diagnostics, certain test makers contend (MedTech Dive)
  • Pfizer CEO confident Covid treatment pill will be effective against omicron variant (CNBC)
  • Antiviral Covid Pills Are Coming. Will There Be Enough Tests? (NYT)
  • Merck slips out drop in efficacy of COVID-19 antiviral over Thanksgiving period (Fierce)
  • Vaccine makers move quickly to confront omicron threat (BioPharma Dive) (NYT) (NPR) (Reuters)
Pharma & Biotech
  • FDA Approves New Imaging Drug to Help Identify Ovarian Cancer Lesions (FDA)
  • Looking past Big Pharma rivals, Blueprint buys a preclinical biotech for $250M+ (Endpoints)
  • Next-gen CAR player Quell Therapeutics drives into the fast lane with major $156M round (Fierce)
  • Spinoff updates: Merck’s Organon and Novartis’ Sandoz (GaBI)
  • Gain Therapeutics presents hopeful data for Parkinson’s, Gaucher treatment (Outsourcing Pharma)
  • A Cure for Type 1 Diabetes? For One Man, It Seems to Have Worked (NYT)
  • Positive Phase III results for fitusiran in hemophilia (Pharmaletter)
  • First trial of a vaccine against Alzheimer’s launches (PMLive)
  • Bob Langer biotech's lead cell therapy remains on FDA hold, but researchers now may know the cause (Endpoints)
  • More manufacturing issues: Fennec preps for second CRL for potential hearing loss drug (Reuters) (Endpoints)
  • EC nod for Lenvima plus Keytruda in two indications (Pharmaletter)
  • Could common antihistamines be the key to boosting immuno-oncology treatments? (Fierce)
  • Roche shareholders vote for share buy-back from Novartis (Pharmaletter)
  • Tiamat Sciences Raises $3M to Empower the Biotech Revolution (Grit Daily)
  • Provepharm cleared to produce APIs for the US market (Pharmaletter)
  • 'What it takes': Beyond the headlines, women are pushing groundbreaking new Alzheimer's treatments forward (Fierce)
  • ‘Start at the top’: Women in biotech on how to break down barriers in the industry (STAT)
  • Alnylam’s new CEO hopes appointment inspires underrepresented groups (STAT)
  • Data manipulation expert Elisabeth Bik compares the tales of 2 accused biotechs: Cassava and Athira (Fierce)
  • US FDA’s Comirnaty Review By The Numbers (Pink Sheet)
  • Placebo Unblinding Process For Pfizer’s COVID Vaccine No Detriment To US FDA Safety Analysis (Pink Sheet)
  • FDA approves AI-based breast cancer screening software MammoScreen (Pharmafile)
  • Latest breakthrough device designations go to brain-computer interface, exo-suit (MedTech Dive)
  • The Future of Gamma Irradiation for Medical Device Sterilization (MD+DI)
  • Are virtual reality headsets a valid tool for treating back pain? Maybe. (Science-Based Medicine)
  • Are Medical Devices Cost-Effective? (PubMed)
Government, Regulatory & Legal
  • Amgen asks Supreme Court to take up its high-profile PCSK9 patent case against Sanofi and Regeneron (Fierce)
  • Unintended Consequences for Software Liability? (Drug & Device Law Blog)
  • Chevron deference at stake in fight over payments for hospital drugs (SCOTUS Blog)
  • As U.S. Hunts for Chinese Spies, University Scientists Warn of Backlash (NYT)
  • Developing nations may give up on the WTO for good if it won’t budge on vaccine patents (The Guardian)
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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