Gilead Stock – Recon: Gilead gets full approval for breast cancer drug Trodelvy; OWS flagged issues at Emergent fac

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Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US

• US allotting 85% less J&J vaccines to states next week, data shows (Reuters)
• The world is watching the FDA’s AstraZeneca decision (Axios)
• Eli Lilly’s arthritis drug fails to prevent mechanical ventilation in COVID-19 patients (Reuters)
• The big hole in America’s plan to fight Covid-19 variants (Politico)
• Gilead wins full approval for drug acquired in Immunomedics deal (BioPharmaDive) (Endpoints) (FDA)
• Startup Behind AstraZeneca Covid Vaccine Plans to File Publicly for US IPO Within Days (Endpoints)
• Top Official Warned That Covid Vaccine Plant Had to Be ‘Monitored Closely’ (NYTimes) (In the Pipeline)

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• Pharmacies Face Peril Without Opioid Settlements, Judge Says (Bloomberg)
• Judge rules Purdue must answer questions about documents showing any link between OxyContin, birth defects (STAT)

In Focus: International

• COVAX vaccines reach more than 100 countries, despite supply snags (Reuters)
• UK-made AstraZeneca vaccines sent to Australia – Sydney Morning Herald (Reuters)
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• India says it has millions of COVID-19 vaccines in hand, denies shortage (Reuters)
• Brazilian health regulator Anvisa authorizes trials for GSK-Medicago COVID vaccine (Reuters)
• EU regulator to probe ethical standards of Sputnik vaccine trials (Reuters) (FT)
• Germany’s vaccine task force to hold talks with Russia on Sputnik V: source (Reuters)
• EU won’t order Russia vaccine, German minister says (The Hill)
• African Union drops plans to buy COVID vaccines from India’s SSI, pivots to J&J (Reuters)
• Merck reaches deal with Austrian antitrust regulators over ‘predatory’ pricing for a cancer drug (STAT)

Coronavirus Pandemic

• Australia backs Pfizer virus vaccine over AstraZeneca for under-50s (Reuters)
• Germany sticks to recommendation on vaccine switch after first Astra dose (Reuters)
• Germany regulator sticks to age limit for AstraZeneca COVID shot (Reuters)
• U.S. begins study assessing allergic reactions to Pfizer and Moderna Covid vaccines (CNBC)
• Mexico, Brazil will not limit AstraZeneca vaccine after UK blood clot warning (Reuters)
• European court backs Czech Republic’s requirement to vaccinate children (Reuters)
• Spain limits AstraZeneca coronavirus vaccine to over 60-year olds (Reuters)
• Tunisia approve Johnson & Johnson COVID-19 vaccine (Reuters)
• AstraZeneca sends legal notice to SII over delays in vax supply (Economic Times)
• Fissures on intellectual property, C-TAP and transparency emerge in WHO local production negotiations (KEI)

Pharma & Biotech

• Pfizer’s boss thinks covid-19 is reshaping Big Pharma for the better (The Economist)
• Series of JAK inhibitor delays may signal an upcoming FDA adcomm (Endpoints)
• PDUFA VII negotiations near finish line with plans to revamp CBER and staff up (Endpoints)
• FDA approves new dosing regimen for cetuximab (FDA)
• Bristol Myers’ Opdivo notches a double win against chemo in esophageal cancer, potentially setting up 1st-line nod (Endpoints)
• BeiGene’s massive biologics plant in China wins first commercial manufacturing nod (Fierce)
• Novartis bags EU, UK licences for MS therapy Kesimpta (PharmaTimes)
• Ionis lays off majority of Akcea staff, expands Sobi Tegsedi deal (Fierce)
• Looking to rebound from rejection in TNBC, Merck‘s Keytruda passes a new kidney cancer test (Endpoints) (Fierce)
• Regulators Call for More Harmonization On Ultra-Rare ATMPs (Pink Sheet)
• Novartis, Artios Pharma Target Cancer in Up-to-$1.3B DDR Collaboration (GEN)
• The CHIC interview: Stéphane Bancel on Moderna‘s overnight transformation, the new timeline on vaccine development and his one regret in 2020 (Endpoints)
• Achilles’ US IPO closed with proceeds of $175m (PharmaTimes)
• Amgen CEO Bob Bradway takes home $20M+ pay package amid bang-up year for sales (Endpoints)
• Recall report: A-S pulls nearly 200,000 acetaminophen bottles off shelves; Apotex yanks ADHD med (Endpoints)
• Female entrepreneurs have long been underrepresented in biotech. An MIT team decided to find out why (Endpoints)
• The Endpoints 100 survey: CEOs changed the way biotechs operate during the pandemic. Things will never be the same again (Endpoints)
• Versant-backed Ventus scores $100M round to turbocharge its dual-platform play at ‘drugging the undruggable’ (Endpoints)
• Eli Casdin and Keith Meister dive back into the SPAC well with $480M haul just weeks after SomaLogic reverse merger (Endpoints)

Medtech

• Medical device firms’ payments to doctors far outstripped those from pharma, study shows (STAT)
• FDA-medtech consortium offers strategy to boost patient engagement in clinical trials (MedtechDive)
• Deaths trigger 6 additional Class I recalls for Medtronic’s HeartWare (MedtechDive)
• Nevro shares full diabetic neuropathy SCS data as it pursues blockbuster opportunity (MedtechDive)
• Hologic inks its largest COVID-powered acquisition yet with $795M for test maker Mobidiag (Fierce)
• Digital diabetes treatment developer Better Therapeutics to go public in SPAC deal (Fierce)
• J&J Vision taps Menicon for contact lenses to slow childhood nearsightedness (Fierce)
• LumiraDx lands on Nasdaq via SPAC with aim to undercut Abbott on price (MedtechDive)
• MDMA, surgeons push Medicare to pull back prior authorization rules (MedtechDive)
• Abbott customizes TriClip heart valve system with upgraded EU approval (Fierce)
• Liquid biopsy maker Nucleix rakes in $55M to develop blood tests to detect lung cancer early (Fierce)
• Turkey’s Updated Medtech Advertising Regulations Will Assist Traceability (MedtechInsight)
• Lucira Health’s Unexpected Sprint To A First-Of-Its-Kind EUA From FDA: The Inside Story (MedtechInsight)

Government, Regulatory & Legal

• Former Indivior medical lead who pled guilty to false opioid marketing now seeks FDA hearing to escape debarment (Endpoints)
• States Too Late To Question Report In MDL, Drugmakers Say (Law360)
• Opioid MDL Judge Picks New Bellwethers, Denies Retaliating (Law360)
• Endo Hit With Default Judgment In Tenn. Opioid Baby Suit (Law360)
• 2nd Circ. Questions Takeda’s ‘Lazarus’ Take On Drug Patents (Law360)
• Ninth Circuit Allows Fraud-on-the-FDA Claim in FCA Whistleblower Suit Against Medtronic, But Affirms Dismissal of Off-Label Promotion Claim (FDA Law Blog)
• Pharma Pushes For Stronger ‘March In’ Rule Despite Changing Political Dynamics, COVID Complications (Pink Sheet)

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.