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