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Regulatory Focus™ > News Articles > 2019 > 7 > Recon: Gilead Licenses Durect Long-Acting Injectable Technology; FDA Rejects Biohaven’s ALS Drug Ove

Recon: Gilead Licenses Durect Long-Acting Injectable Technology; FDA Rejects Biohaven’s ALS Drug Over Manufacturing Concerns

Posted 22 July 2019 | By Michael Mezher 

Recon: Gilead Licenses Durect Long-Acting Injectable Technology; FDA Rejects Biohaven’s ALS Drug Over Manufacturing Concerns

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • Busy Gilead crew throws struggling biotech a lifeline, with some cash upfront and hundreds of millions in biobucks for HIV deal (Endpoints) (Press)
  • FDA Approves First Lyrica Generics From 9 Sponsors (Focus)
  • The Four Ordinary People Who Took On Big Pharma (NYTimes)
  • Amarin's $400M-plus offering put investors on edge. Is a buyout off the table? (Fierce)
  • Biohaven's treatment for Lou Gehrig's disease fails to win FDA nod (Reuters) (Endpoints)
  • Celgene's Otezla becomes first and only FDA-approved therapy for oral ulcers in Behçet’s Disease (Pharmafile) (PMLive) (Endpoints) (Press)
  • Fight for CRISPR patents gets knottier, as MilliporeSigma makes new claims (STAT) (Patent Docs)
  • Revamped OxyContin was supposed to reduce abuse, but has it? (AP)
  • Alzheimer’s: scientists head back to the drawing board - once-shunned ideas get an audience (STAT)
  • US records 25 new measles cases as outbreak spread to Ohio, Alaska (Reuters)
  • PhRMA scrambles to fight potential drug pricing reforms in budget deal (STAT)
  • The biggest civil trial in U.S. history will start with two Ohio counties (Washington Post)
  • Inside The Pharmaceutical Lobby's Campaign for More Government Subsidies Through Medicare Part D (Forbes)
Sponsored Content: Hear from the first Notified Body designated to the new EU-MDR In Focus: International
  • GSK sets out strategy to double drug discovery success (Financial Times)
  • WHO recommends dolutegravir as preferred HIV treatment option in all populations (WHO)
  • Time to make essential cancer drugs more affordable (Financial Times)
  • Takeda makes Crohn’s disease case for subcutaneous Entyvio (PMLive) (Endpoints)
  • NICE to review its decision making processes (Pharmafile)
  • MHRA gives Bavencio, Inlyta combo Early Access to Medicines status (PharmaTimes)
  • UK prescribed ‘unnecessarily long courses’ of antibiotics (PharmaTimes)
  • Congo health minister resigns over government handling of Ebola (Reuters)
  • J&J files new Darzalex formulation in US and Europe (PMLive)
  • The Indian pharmaceutical industry is in denial over drug-quality charges (STAT)
  • Experts Talk over Biosimilar Challenges, Chide Unstable Supplies and Indication Gaps (PharmaJapan)
  • Biosimilar drugs a boon to be applauded as they provide equivalent treatment at – sometimes – half the price (The Globe & Mail)
Pharmaceuticals & Biotechnology
  • 5 questions going into this week's biopharma earnings (BioPharmaDive)
  • Biosimilar Approvals And The BPCIA: Too Soon To Give Up (Health Affairs)
  • Some Big Pharmas stepped up their game on data transparency — but which flunked the test? (Endpoints)
  • FDA Discusses RWD, RWE With Industry, Academia (Focus)
  • How Risky Is Amgen's At-Risk Launch Of Herceptin, Avastin Biosimilars? (Pink Sheet-$)
  • 8 More Big Pharma Events in 2019 You Don't Want to Miss (Yahoo)
  • 'Smart Pill' Schizophrenia Drug Unlikely To Move Payers (Forbes)
  • How best to describe precision medicine beyond oncology? ‘It’s complicated.’ (MedCity)
  • A half step forward for heart failure as FDA guidance leaves key question unanswered (BioCentury)
  • Breaking the death spiral: Hal Barron talks about transforming the moribund R&D culture at GSK in a critical year for the late-stage pipeline (Endpoints)
  • Welcome To The Estimand: Patient-Reported Outcome Framework Gets Warm Response At FDA/ASCO Workshop (Pink Sheet-$)
  • A personalized CAR-T to attack every solid tumor? Pact Pharma has a plan (Fierce)
  • Roche expands the Global Access Program beyond HIV to also include diagnostic tests for Tuberculosis, Hepatitis, and Human Papillomavirus (Press)
  • Vertex gets NDA going for CF triple combo; Disarm woos rare disease expert Alvin Shih as CEO (Endpoints)
  • The Art of Off-Label Rx (Medpage)
  • Yellow Wood Partners to acquire iconic Dr. Scholl’s™ brand from Bayer (Press)
  • Clinical promise of next-generation complement therapeutics (Nature)
  • Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Bar Code Label Requirement for Human Drug and Biological Products (FDA)
  • Bayer Statement on Voluntary Recall of Two Lots of Kogenate® FS Antihemophilic Factor (Recombinant) in the United States (FDA)
Pharmaceuticals & Biotechnology: Study Results, Filings & Designations
  • Intec flunks phase 3 Parkinson's test against Merck drug (Fierce) (Press)
  • Vanda Pharmaceuticals FDA Update for HETLIOZ® in the Treatment of Jet Lag Disorder (Press)
  • Vertex Submits New Drug Application to the U.S. FDA for Triple Combination Regimen of VX-445 (Elexacaftor), Tezacaftor and Ivacaftor in Cystic Fibrosis (Press)
  • Apic Bio’s APB-102 Receives Orphan Drug Designation from the FDA for the Treatment of Genetic SOD1 ALS (Press)
  • Biohaven Provides Update On Phase 2/3 Alzheimer's Disease Clinical Trial: Over 400 Patients Enrolled (Press)
  • CStone receives approval in China to initiate ivosidenib Phase I bridging registrational study for the treatment of IDH1 mutant relapsed or refractory AML (Press)
  • ViiV Healthcare presents positive 96-week data from phase III study of investigational fostemsavir in heavily treatment-experienced patients with HIV at IAS 2019 (Press)
  • Theravance Biopharma Reports New Data from Phase 2 Study of Ampreloxetine (TD-9855) in Oral Presentation at 32nd European Neurology Congress (Press)
  • Tiziana Reports Phase 2a Clinical Data with Milciclib Monotherapy in Sorafenib-refractory or -intolerant patients with unresectable or metastatic Hepatocellular Carcinoma (Press)
  • Resolve Therapeutics Announces Completion of Enrollment for Phase 2a Study of RSLV-132 for the Treatment of Lupus (Press)
Medical Devices
  • Philips jumps on surging Q2 profits (MassDevice)
  • First medical product cleared in U.S. for use on certain injuries caused by sulfur mustard (PHE)
  • Medtronic inks deal for Viz.ai’s stroke tech (MassDevice) (Press)
  • Zoll Medical picks up Mobilize RRS (MassDevice)
  • Med-El USA lands first FDA approval for single-sided deafness implant (MassDevice) (Press)
  • Baxter Announces FDA Approval of Myxredlin, The First and Only Ready-To-Use Insulin for IV Infusion (Press)
US: Assorted & Government
  • Verma to bash 'public option' (Politico)
  • Federal Judge In Ohio Releases Trove Of Opioid Sales Records (NPR)
  • Ohio prosecutors file charges against opioid distributor Miami-Luken (Pharmafile)
  • Price Increases of Protected-Class Drugs in Medicare Part D, Relative to Inflation, 2012-2017 (JAMA)
  • One from out of Left Field (Drug & Device Law)
  • Lawmakers To FDA: Speed Review Of Bulk Drug Substances For 503B List (IHP)
  • Top Democratic presidential candidates aligned on drug prices (BioCentury)
  • Tennessee Must Mediate With Prisoners Over Hepatitis C Drugs (NYTimes)
  • Opioid and price fixing legal liabilities mount for generic companies (BioPharmaDive)
  • J&J faces a crucial hearing Monday over thousands of talc baby powder lawsuits (CNBC)
  • Judge denies J&J’s request to transfer 2,400 talc lawsuits to federal court (CNBC)
  • FDA launches its first youth e-cigarette prevention TV ads, plans new educational resources as agency approaches one-year anniversary of public education campaign (FDA)
  • Solutions to Reduce Fraud, Waste, and Abuse in HHS Programs (HHS OIG)
  • Request for Human Embryonic Stem Cell Line to be approved for Use in NIH Funded Research (HHS)
  • Four Officials Ejected at Health Agency; DOD Contracts Disrupted (Bloomberg)
Upcoming Meetings & Events Europe
  • EU Ombudsman Concludes Inquiry on EMA Interactions With Medicine Developers (Focus)
  • Government to invest £16m in 'life-saving' medical advances (PharmaTimes)
  • Government spend £9.2 billion on private healthcare providers for NHS in 2018-19 (Pharmafile)
  • 10th Edition of Ph. Eur.: CEP holders are invited to update their applications (Council of Europe)
  • ABPI President: Collaboration key to getting new medicines to patients (NHE)
  • Chief Medical Officer annual report 2019: partnering for progress (MHRA)
Asia
  • NMPA Issued the Announcement on the Requirements for Dossiers and Samples for Verification and Inspection of Specifications for Overseas New Drugs Urgently Needed in Clinical Settings (NMPA)
India
  • India participates in only 2 to 3% of global clinical trials under evolving regulatory scenario (PharmaBiz)
  • Genetic tests gaining popularity for diagnosis & treatments in India (Economic Times)
  • Hospitals still not displaying medical device prices, consumer groups say (Economic Times)
  • USFDA completes inspection of Strides Pharma Bengaluru plant (Economic Times)
Canada
  • ICH Global Meeting on ICH E8(R1) Guideline on General Considerations for Clinical Trials (Health Canada)
  • Mystery surrounds ouster of Chinese researchers from Canadian laboratory (Science)
Australia
  • Webinar: The difference in regulatory oversight for a Class I versus a Class IIa medical device? (TGA)
  • Medical Device Premarket Cybersecurity: TGA Finalizes Guidance (Focus)
Regulatory Reconnaissance is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory news stories from around the globe. Each weekday morning, we aim to bring you the latest highlights of new approvals, meetings, legal and political developments, regulations and guidance, and the latest trends with the potential to impact regulatory affairs professionals and the industry in which they work.
 
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