Regulatory Focus™ > News Articles > 2019 > 10 > Recon: Pfizer Pays $250M to License Akcea Antisense Drug; Opioid Victims to Sit on Purdue Bankruptcy

Recon: Pfizer Pays $250M to License Akcea Antisense Drug; Opioid Victims to Sit on Purdue Bankruptcy Committee

Posted 07 October 2019 | By Michael Mezher 

Recon: Pfizer Pays $250M to License Akcea Antisense Drug; Opioid Victims to Sit on Purdue Bankruptcy Committee

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • How Pete Buttigieg would lower drug prices (Politico) (STAT) (Boston Globe)
  • Victims gain a voice to help guide Purdue Pharma bankruptcy (AP)
  • Sacklers Received as Much as $13 Billion in Profits From Purdue Pharma (WSJ)
  • Pfizer fronts $250M to nab antisense drug from Akcea/Ionis in up to $1.5B deal (Endpoints) (Press)
  • Sarepta gene therapy improves muscle function in rare limb-girdle disease (STAT) (PMLive)
  • ‘It shows how much pharma has on their plate’: Congress just quietly passed a bill that will cost drug makers $3 billion (STAT)
  • FDA OKs Trifarotene, First New Retinoid Acne Cream in 20 Years (Medscape) (Endpoints) (Press)
  • J&J pledges $500m investment into HIV and tuberculosis R&D (PMLive)
  • Pharmaceutical Companies Are Luring Mexicans Across the US Border to Donate Blood Plasma (ProPublica)
  • US retains measles-elimination status despite worst outbreak in quarter century (Reuters)
  • Australia Just Had A Bad Flu Season. That May Be A Warning For The US (NYTimes)
In Focus: International
  • Doctors who deciphered body's response to oxygen win Nobel Medicine Prize (Reuters) (STAT)
  • Vectura, Sandoz win ruling on inhaler packaging case against GSK (Reuters)
  • These 4 biotechs are already bragging about their ‘Nobel Prize-winning’ bona fides (STAT)
  • Sensyne, MHRA form research collaboration (PharmaTimes)
  • Merck, BMS, AbbVie blockbusters will rule pharma sales in 2025: report (Fierce) (PharmaTimes)
  • PAHO secures significant price reductions for hepatitis C medicines (PAHO)
  • 430 days and 1000 victories in the fight against Ebola in the Democratic Republic of the Congo (WHO 1, 2)
  • Australia to fund research on medicinal cannabis as demand grows (Reuters)
  • The End Of Guinea Worm Was Just Around the Corner. Not Anymore (NPR)
Pharmaceuticals & Biotechnology
  • ‘It’s really a horrific situation’: What one doctor thinks about drug shortages‚ and how to solve them (STAT)
  • A Warning Letter Trend Surprise: Good In India, Bad In South Korea (Pink Sheet-$)
  • Cancer Is Still Beating Us—We Need a New Start (WSJ)
  • Virus Linked To Mysterious Disease That Weakens Children's Limbs (NPR)
  • Current Supply of Heparin for U.S. Market Not Impacted By African Swine Fever in China (FDA)
  • Glenmark gets FDA warning letter for plant that produced defective creams (Fierce)
  • Young people are poisoning themselves at alarming rates with over-the-counter drugs (Vox)
  • J&J poaches Bayer exec Jim Swanson as chief information officer (Endpoints)
  • FDA Unveils New Tables for Submitting Bioanalytical Methods (Focus)
  • Online services for birth control pills appear safe to use, study says (NBC)
  • Gilead's Descovy nabs PrEP nod. Next step: Convert Truvada patients before generics hit (Fierce)
  • Acorda loses its last shot at protecting its cash cow franchise drug. It’s up to Inbrija now (Endpoints)
  • Gilead chief O'Day recruits top Genentech researcher as new CMO in the wake of a high-level R&D exodus (Endpoints)
  • Oxford spinout MiroBio bags £27M for autoimmune R&D (Fierce)
  • Ness Bermingham looks to lead the wave of RNA editing at new Atlas upstart Korro Bio (Endpoints)
  • Dynavax continues to shed staffers as CSO to leave with no replacement plan (Fierce)
  • Ophthalmology biotech upstart is asking investors to bet $85M-plus on their late-stage rival to Restasis and Xiidra (Endpoints)
  • Antibody research graduates from a top Oxford lab into the biotech world — with $34M to fund R&D work (Endpoints)
  • We’ll see this week if the public markets’ love affair with biotech unicorns is still running hot — or not (Endpoints)
  • Precision IBD Rebrands as Prometheus and Strikes R&D Deal With Takeda (Xconomy)
Pharmaceuticals & Biotechnology: Study Results, Filings & Designations
  • Janssen Submits Application to U.S. FDA Seeking Approval of STELARA®(ustekinumab) for the Treatment of Pediatric Patients with Moderate to Severe Plaque Psoriasis (Press)
  • Arbutus stops early hepatitis B study on safety concerns (BioPharmaDive)
  • DBV Technologies Announces FDA Acceptance of BLA filing for Viaskin Peanut for the Treatment of Peanut Allergy (Press)
  • Pfizer reports positive phase 3 data in atopic dermatitis (Pharmafile)
  • U.K. launches trial of Boston Pharma's resistance-busting combo in triple-negative breast cancer (Fierce)
  • J&J steps forward in PARP prostate-cancer race with FDA ‘breakthrough’ for Zejula (Fierce) (Press)
  • Eagle Pharmaceuticals’ Japanese Licensing Partner SymBio Announces its Submission of a New Drug Application for TREAKISYM® Ready-To-Dilute Formulation (Press)
  • ACADIA Pharmaceuticals Presents Additional Positive Data from the Phase 2 CLARITY Study with Pimavanserin in Adjunctive Major Depressive Disorder at 2019 Psych Congress (Press)
  • Verastem Oncology Announces Dosing of First Patient in Yakult Honsha Co., Ltd.’s Japanese Bridging Study Evaluating COPIKTRA® (Duvelisib) in Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (Press)
  • Yumanity Therapeutics Initiates Phase 1 Clinical Trial of Lead Candidate YTX-7739 for the Treatment of Parkinson’s Disease (Press)
  • Amylyx Pharmaceuticals Announces Last Patient Completes Last Study Visit in CENTAUR Phase 2 Study of AMX0035 in ALS (Press)
  • Advaxis Announces Updated Prolonged Survival Data in Phase 1/2 ADXS-PSA Trial (Press)
  • DURECT Announces Completion of Enrollment in its Phase 2a Clinical Trial of DUR-928 in Psoriasis and 50% Enrollment in its Phase 1b DUR-928 Clinical Trial in NASH (Press)
Medical Devices
  • Bioelectronics ‘jump-start’ the next wave of device therapeutics (McKinsey)
  • How Medtronic Is Building a 'Spine Ecosystem' (MDDI)
  • CSA Medical touts one-year feasibility data for RejuvenAir bronchitis device (MassDevice)
  • ProTom Receives U.S. FDA 510(k) Clearance for Its Radiance 330® Single Room Proton Therapy System (Press)
  • Aethlon Medical Announces FDA Approval Of IDE For Oncology Indications (Press)
  • Intersect ENT Announces Results From the ASCEND Study of Company’s Investigational Drug-Coated Balloon for Sinus Dilation (Press)
  • Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Investigational Device Exemptions Reports and Records (FDA)
US: Assorted & Government
  • Full-Year CR: Better Than a Shutdown, But … (Alliance for a Stronger FDA)
  • Nevada Fines Drugmakers $17M for Failing to Comply With Drug Pricing Law (Focus)
  • Statement on consumer warning to stop using THC vaping products amid ongoing investigation into lung illnesses (FDA)
  • Elizabeth Holmes’ lawyers in Theranos civil case want out because she can’t pay them (CNBC)
  • Owner of Tampa-Area Medical Marketing Company Sentenced to Prison for DNA Testing Fraud Scheme (DOJ)
  • Fed. Circ. Won't Revive 23AndMe Patent Axed Under Mayo (Law360-$)
  • Stupid Expert Fees (Drug & Device Law Blog)
  • USPTO Proposes Revisions to PTA Rules in View of Supernus v. Iancu (Patent Docs)
  • Think Twice Before Sharing: Court Compels Disclosure of Settlement Presentations in Relator’s Qui Tam Suit (FDA Law Blog)
Upcoming Meetings & Events Europe
  • MDR Guidance Addresses Transitional Provisions (Focus)
  • EMA’s PRAC recommends four-week limit for use of high-strength estradiol creams (PharmaLetter-$)
  • EMA says delivering 4th-qtr work program will be challenging as it readies for Brexit (PharmaLetter-$)
India
  • Regulator may go over the counter to tackle issue of drug overdose (Economic Times)
  • ICRA forecasts Indian pharma industry to remain at 11-13% growth in FY2020 (Pharmabiz)
  • Anti Corruption Bureau in Telangna arrests 8 IMS officials for involvement in Rs.300 crore fake medicine supply scam (Pharmabiz)
  • NIPER Hyderabad signs MoU with AHERF India to boost research in pharmaceuticals (Pharmabiz)
  • Strides Plans Injectables Re-entry As Mylan Non-Compete Nears End (Scrip-$)
  • Indian pharma working to strengthen Middle East market as Union govt propels its economic-trade relations (Pharmabiz)
General Health & Other Interesting Articles
  • Celiac families may not need two toasters (Reuters)
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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