Recon: Gene Therapy Boosts Novartis’ Q4 Sales; Spring Bank Stops Hep B Drug After Patient Death

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

• Spring Bank stops hepatitis drug development after patient dies during trial (Reuters) (Endpoints)
• OxyContin maker Purdue is 'Pharma Co X' in U.S. opioid kickback probe - Sources (Reuters) (STAT)
• Biotech earnings preview: Unsettled investors hoping for strong 2020 outlooks (STAT)
• Johnson & Johnson working on vaccine for deadly coronavirus (Reuters) (Press)
• FDA approves Teva's Ajovy autoinjector for treatment of migraine (Pharmafile) (Press)
• FDA Warns Purell to Stop Claiming It Can Prevent Ebola or Flu (NYTimes) (Washington Post)
• Bias in biotech funding has blocked companies led by women (Washington Post)
• FDA Commissioner Stephen Hahn on His Plans for Transforming the Agency (TexasMonthly)
• No Shortage of Controversies for New FDA Commissioner (WSJ)
• In landmark step, judge does not defer to FDA in stem cell clinic chain case, orders full trial (IPSCell) (LA Times)

In Focus: International

• Novartis gene therapy for fatal childhood disease delivers strong sales during fourth quarter (STAT) (Financial Times) (PMLive)
• Novartis sees no coronavirus disruption amid China growth (Reuters)
• European Parliament votes to back terms of UK's exit (BBC)
• China says death toll from coronavirus outbreak rises to 132 (Reuters)
• WHO to reconvene emergency committee to assess global coronavirus threat (STAT) (CNBC)
• Russia and China are working on virus vaccine: consulate (Reuters)
• Hong Kong researchers have already developed coronavirus vaccine but need time to test it (SCMP)
• Researchers Are Racing to Make a Coronavirus Vaccine. Will It Help? (NYTimes) (CNBC)
• European Commission expands use for Janssen’s Erleada (PharmaTimes) (Press)
• EMA begins review of Kite’s CAR-T for mantle cell lymphoma (PMLive)
• Crunch Time For Protection Of New Therapeutic Uses In Europe (Pink Sheet-$)

Pharmaceuticals & Biotechnology

• Troubled Alkermes eyes November OK for new antipsychotic (PMLive)
• In a pivot, Decibel Therapeutics loses its founding CEO — and some of its discovery programs (STAT) (Xconomy)
• Biotech can — and must — reshape the pricing debate and protect future innovation (STAT)
• Novartis AveXis President Lennon On Rebuilding Trust With FDA, Zolgensma Trial Hold, And More (Pink Sheet-$)
• What The US-China Trade Deal Means For Drug Cos. (Law360-$) (AAM)
• Vyndaqel a bright spot as Pfizer comes under pressure (PMLive)
• Shifts in pharma’s 2020 digital health landscape (mobihealthnews)
• BDO CFO Outlook Survey: Life Sciences (BDO)
• Weaponizing Truth Against Opioids (NYTimes)
• Putting buybacks on hold, Pfizer’s CEO is plotting a string of important PhII deals in the year ahead. You’ve been alerted (Endpoints)
• What in the world is a MINOR CRL, Amphastar? (Endpoints)
• Novartis halts PhII CML study for next-gen allosteric drug due for a pivotal readout later this year (Endpoints)
• Following a NASH crash, Conatus turns the keys over to regenerative med player (Endpoints)
• Rare disease biotech Passage Bio nabs Deerfield veteran as CEO (Fierce) (Endpoints)
• Cancer patients facing delays in getting ‘innovative’ drugs (PharmaTimes)
• FDA strengthens warning that untreated constipation caused by schizophrenia medicine clozapine (Clozaril) can lead to serious bowel problems (FDA)
• Histogen, Timber Pharma Plan Reverse Mergers to Join Public Markets (Xconomy)
• Request for Nominations for Voting Members for the Patient Engagement Advisory Committee (FDA)

Pharmaceutical & Biotechnology: Study Results, Filings & Designations

• Racing Blueprint, Lilly drug gets priority review for RET hopeful (Fierce) (Endpoints)
• Surprise! Pfizer And Lilly File Tanezumab For Pain With FDA Despite Safety Questions (Scrip-$)
• Akcea, Pfizer hit midphase goal, but data raise doubts about chances in NAFLD, diabetes (Fierce) (Endpoints)
• Polarean Imaging plc Announces Positive Results From Pivotal Phase III Clinical Trials (Press)
• Monoferric® (ferric derisomaltose) injection is approved by the US FDA for the treatment of iron deficiency anemia (Press)

Medical Devices

• BioIntelliSense’ BioSticker sensor approved by the FDA (Pharmafile)
• MedTech ON AIR: the first episode is online! (MedtechEurope)

US: Assorted & Government

• Expiring tool to fight fentanyl saved in Senate but faces uncertain future in House (CNN)
• Where the Purdue Pharma-Sackler legal saga stands (Reuters)
• U.S. reports no new deaths tied to vaping, lung illness cases rise to 2,711 (Reuters)
• California Dreaming Part 2: The Constitutional Challenge (FDA Law Blog)
• Washington State Court Rules that Pharmacy Cannot Be Liable for Failure to Warn (Drug & Device Law)

Upcoming Meetings & Events

• FDA Advisory Committee Calendar
• Meeting of the Oncologic Drugs Advisory Committee Meeting Announcement – 26 February 2020
• ISO/ICH E2B(R3) Individual Case Safety Reporting in the EU: Hands-on training course using the EudraVigilance System – Amsterdam – 4-6 March 2020

Europe

• Member States meet with the European Commission in Brussels on January 29^th to discuss the protection of personal data in the health sector (European Commission)
• Is NICE’s Pricing Influence On The Wane? (Pink Sheet-$)
• After Brexit, U.K. scientists face a long road to mend ties with Europe (Science)
• Early Advice Crucial For Navigating Denmark’s New Appraisal System (Pink Sheet-$)
• State of play: European Commission provides latest figures on Notified Body MDR, IVDR designations (Emergo)
• Class 4 Medicines Defect Information: Dr. Reddy's Laboratories (UK) Ltd, Finasteride 5mg Tablets, PL 08553/0261 (EL (20)A/03) (MHRA)
• Chugai settles with UK research bodies over Actemra (PharmaLetter-$)

Asia

• South Korea issues final revisions to regulations for medical device importation requirements (Emergo)

India

• Torrent Pharmaceuticals puts faith in local market, to focus on new drug launches (Economic Times)
• WHO Global TB Programme includes ICMR-developed TrueNat as initial test for diagnosing TB (Pharmabiz)
• CDSCO mandates processing of post approval changes in clinical trial applications within 15 days (Pharmabiz)

Coronavirus Outbreak

• What the best public health minds know — and don’t know — about Wuhan coronavirus (Politico)
• WHO weighs science and politics in global virus emergency decision (Reuters)
• China agrees to WHO sending experts to study virus (Reuters)
• Swiss seek access to EU early-warning system as coronavirus spreads (Reuters)
• U.S., Japan pull nationals from China, big virus economic hit forecast (Reuters)
• Australian lab first outside of China to copy coronavirus, helping vaccine push (ABC Australia) (Reuters)
• White House holds off on suspending China-U.S. flights amid virus outbreak (Reuters)
• UNICEF sends six tonnes of masks and other gear to help fight China virus (Reuters)
• EU Commission advises staff to suspend non-essential travel to China (Reuters)
• Novel coronavirus 2019-nCoV (European Commission)
• Chinese family in UAE diagnosed as first virus cases in Middle East (Reuters)
• China's Sichuan province reports first death from coronavirus - state media (Reuters)
• Britain to isolate anyone returning from Wuhan, minister says (Reuters)
• Beijing drugstore fined for hiking mask prices amid virus outbreak (Reuters)
• AdvaMed Working Closely with U.S., Chinese Governments on Coronavirus Response, Readiness (AdvaMed)

General Health & Other Interesting Articles

• Amid Coronavirus Scare, U.S. Counts Thousands Of Flu Deaths (NPR)

Regulatory Reconnaissance is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe.
 
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