Recon: Gene Therapy Boosts Novartis’ Q4 Sales; Spring Bank Stops Hep B Drug After Patient Death
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In Focus: US
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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)
- 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-$)
- Troubled Alkermes eyes November OK for new antipsychotic (PMLive)
- In a pivot, Decibel Therapeutics loses its founding CEO — and some of its discovery programs (STAT) (Xconomy)
- Biotech can — and must — reshape the pricing debate and protect future innovation (STAT)
- Novartis AveXis President Lennon On Rebuilding Trust With FDA, Zolgensma Trial Hold, And More (Pink Sheet-$)
- What The US-China Trade Deal Means For Drug Cos. (Law360-$) (AAM)
- Vyndaqel a bright spot as Pfizer comes under pressure (PMLive)
- Shifts in pharma’s 2020 digital health landscape (mobihealthnews)
- BDO CFO Outlook Survey: Life Sciences (BDO)
- Weaponizing Truth Against Opioids (NYTimes)
- Putting buybacks on hold, Pfizer’s CEO is plotting a string of important PhII deals in the year ahead. You’ve been alerted (Endpoints)
- What in the world is a MINOR CRL, Amphastar? (Endpoints)
- Novartis halts PhII CML study for next-gen allosteric drug due for a pivotal readout later this year (Endpoints)
- Following a NASH crash, Conatus turns the keys over to regenerative med player (Endpoints)
- Rare disease biotech Passage Bio nabs Deerfield veteran as CEO (Fierce) (Endpoints)
- Cancer patients facing delays in getting ‘innovative’ drugs (PharmaTimes)
- FDA strengthens warning that untreated constipation caused by schizophrenia medicine clozapine (Clozaril) can lead to serious bowel problems (FDA)
- Histogen, Timber Pharma Plan Reverse Mergers to Join Public Markets (Xconomy)
- Request for Nominations for Voting Members for the Patient Engagement Advisory Committee (FDA)
- Racing Blueprint, Lilly drug gets priority review for RET hopeful (Fierce) (Endpoints)
- Surprise! Pfizer And Lilly File Tanezumab For Pain With FDA Despite Safety Questions (Scrip-$)
- 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)
- BioIntelliSense’ BioSticker sensor approved by the FDA (Pharmafile)
- MedTech ON AIR: the first episode is online! (MedtechEurope)
- 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)
- 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
- Member States meet with the European Commission in Brussels on January 29th 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-$)
- South Korea issues final revisions to regulations for medical device importation requirements (Emergo)
- 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)
- 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)
- Amid Coronavirus Scare, U.S. Counts Thousands Of Flu Deaths (NPR)
Need to contact the editor of Regulatory Reconnaissance? Email us at [email protected].
A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.