Recon: FDA approves Antares’ oral testosterone drug; Europe’s biotech industry face tough times, restructuring amid ‘dwindling’ cash
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.In Focus: US
- Antares, Lipocine expand testosterone offerings with FDA nod for a new, oral med for hypogonadism (Fierce) (Endpoints)
- Biden likely to sign a bill that would crack down on China's chokehold on the antibiotic supply (Endpoints)
- Key senators eye new, more ambitious legislation to lower insulin prices (STAT)
- Inflation caused ‘unprecedented’ drops in net pharmaceutical prices, analysis finds (STAT)
- ImmunoGen files ovarian cancer ADC with FDA, a week after scaring investors with iffy survival data (Fierce)
- Medicare Alzheimer's Drug Study Criteria Would Be Out Of Reach In Many States – Analysis (The Pink Sheet)
- Adagio presses forward with their FDA pitch for Covid antibody — despite Omicron flaws (Endpoints) (Fierce)
- Lawmakers and a Pelosi aide turn lobbyist to push for new health agency’s independence (STAT)
- Pfizer's bowel disease drug succeeds in second late-stage study (Reuters)
- Europe's Biotechs In Battle For Survival (Scrip)
- EMA starts review of Sanofi-GSK COVID vaccine application (Reuters)
- UK Clinical Trial Numbers Still ‘Buoyant’ After Brexit (The Pink Sheet)
- Too Fast, Too Much? Japan Cuts Prices By 6.7% As Annual Revisions Bite (The Pink Sheet)
- Roche anti-TIGIT cancer immunotherapy fails in first late-stage clinical trial (STAT) (Fierce) (Reuters)
- EU health ministers call for common approach to 2nd boosters for elderly (Reuters)
- Ukraine war offers hard lessons for clinical research industry: H1 (Outsourcing Pharma)
- WHO launches transitional list of globally recognized regulators, announces Egypt, Nigeria regulators reach ‘high maturity level’ (WHO)
- WHO releases strategic response plan to end COVID-19 emergency (WHO)
- BioNTech to expand trial programme for more anti-Omicron vaccine options (Reuters)
- ‘Super-Immune’ People May Hold Key to Better Vaccines (Bloomberg)
- No agreement yet on WTO vaccine waiver compromise, USTR's Tai says (Reuters)
- CDC: If you got J&J’s vaccine and booster, consider an mRNA shot now (Washington Post)
- Peter Hotez and Maria Bottazzi’s ‘forgotten’ vaccine approved in Botswana (Endpoints)
- Sanofi Bets Big On IgM ‘Super Antibodies’ In Potential $6bn Cancer and Immunology Deal (Scrip)
- ‘We’ll Be First With Off-The-Shelf CAR-T,’ Vows Precision Biosciences – And Hopes To Win Over Gene-Editing Skeptics (Scrip)
- Purdue shells out a little more cash for a non-profit biotech working on naloxone OTC nasal spray (Endpoints)
- Neuron23 snags $100M and a new Parkinson’s disease candidate (Fierce)
- From textiles to therapies: North Carolina’s journey to a booming biotech hub (BioPharma Reporter)
- Amazon jumps into decentralized trials push as AWS partners with startup to cut down on inefficiencies (Endpoints)
- Restructuring gives embattled Orphazyme three paths to survival (Medwatch)
- Pharma partnerships with digital therapeutics players to watch (STAT)
- Notified body update dampens hopes of near-term surge in IVDR capacity (MedTech Dive)
- European Regulatory Round-Up March 2022: Unprecedented Hiatus In Implementation Announcements (MedTech Insight)
- Minute Insight: FDA Clears Sky Medical’s Latest Blood Flow-Boosting Geko Device (MedTech Insight)
- Philips issues cybersecurity warning over e-Alert MRI monitoring system (Fierce) (MedTech Dive)
- Merck Must Face Claims Alleging HPV Shot Warning Inadequate (Bloomberg)
- Novo Nordisk Beats Appeal in Diabetes Drug Cancer Litigation (Bloomberg)
- HHS seeks to penalize another drugmaker amid legal clash over drug discount program (STAT)
- CVS, Teva, and Allergan reach deal with Florida over the opioid crisis (STAT) (Reuters) (Bloomberg)
- Theranos Judge Seals Courtroom For Balwani’s Brady Hearing (Law360)
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