Regulatory Focus™ > News Articles > 2019 > 7 > Recon: Pfizer to Merge Off-Patent Drug Business With Mylan

Recon: Pfizer to Merge Off-Patent Drug Business With Mylan

Posted 29 July 2019 | By Michael Mezher 

Recon: Pfizer to Merge Off-Patent Drug Business With Mylan

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • Pfizer to Merge Its Off-Patent Drug Unit With Mylan (NYTimes) (Financial Times) (STAT) (WSJ) (NBC) (Bloomberg) (Forbes) (Press)
  • Pfizer posts 30% rise in quarterly profit (Reuters) (Press)
  • Little-known generic drugmakers played central role in opioid crisis, records show (Washington Post)
  • Cummings plans to call pharma executives to testify about drug costs (The Hill)
  • Exact Sciences to buy Genomic Health for $2.8 billion (CNBC) (MedTechDive)
  • Assailing High Drug Prices, Sanders Heads to Canada for Affordable Insulin (NYTimes) (Reuters)
  • With $2.1 million price tag, families fight to get lifesaving drug for babies covered (NBC)
In Focus: International
  • Swiss to Take On Big Pharma With Cheaper Cancer Treatment (Bloomberg)
  • Novartis heart drug fails trial, curbing growth prospects (Reuters) (Endpoints)
  • North takes on South in UK’s life science industry (Financial Times)
  • Thrashed by a 'surprise' rival, Sanofi writes off $2B on soured hemophilia deal (Endpoints) (BioPharmaDive) (Fierce)
  • Sanofi raises outlook after strong second quarter (Reuters) (Press)
  • Wellcome Trust joins warning for no-deal Brexit, calls on Johnson to cast R&D vision (Endpoints)
  • Woodford's unraveling continues as listed fund considers kicking him out as manager (Endpoints)
  • ViiV submits regulatory application to EMA for investigational HIV combo (PharmaTimes) (Press)
  • Korea Races For IPF Drug Development Amid Keen Global Interest (Scrip-$)
  • Sanofi ends partnership with Lexicon to develop diabetes drug (Reuters)
  • BMS Announces European Commission Approval of Pending Acquisition of Celgene (Press)
Pharmaceuticals & Biotechnology
  • In the US, getting the right medicine after a heart attack may depend on where you live (Reuters)
  • Antibiotics Companies Plot Course Past Market Obstacles (WSJ)
  • Sickle Cell Patient Reveals Why She Is Volunteering For Landmark Gene-Editing Study (NPR)
  • New Protocol For HIV Prevention Drug Reduces The Number Of Pills Required (KHN)
  • We have answers to some of biotech’s burning questions for 2019 — and some new issues to watch (STAT)
  • After painting a poor safety profile, Pfizer and Eli Lilly are shooting for a new pain drug OK anyway (Endpoints)
  • Pfizer Is King Of The US Biosimilar Hill (Pink Sheet-$)
  • $20B-plus? Merck keeps racking up PhIII successes, scoring on triple negative breast cancer challenge as analysts drive up peak sales estimates (Endpoints)
  • Zealand Pharma CSO quits to take up another biotech post (Fierce)
Pharmaceuticals & Biotechnology: Study Results, Filings & Designations
  • Genfit's elafibranor wins orphan status for primary biliary cholangitis; Cidara stock soars on positive anti-fungal mid-stage data (Endpoints)
  • Alterity Therapeutics Announces Successful Completion of Phase 1 Clinical Trial (Press)
  • Merck’s KEYTRUDA® (pembrolizumab) in Combination with Chemotherapy Met Primary Endpoint of Pathological Complete Response (pCR) in Pivotal Phase 3 KEYNOTE-522 Trial in Patients with Triple-Negative Breast Cancer (TNBC) (Press)
  • Kodiak Sciences Announces Positive Interim Data from Ongoing Phase 1b Clinical Study of KSI-301, a Novel Anti-VEGF Antibody Biopolymer Conjugate for Treatment of Wet AMD, Diabetic Eye Disease, and Retinal Vein Occlusion, at the American Society of Retina Specialists 2019 Annual Meeting (Press)
  • CANbridge Pharmaceuticals Submits New Drug Application for Hunterase® for the Treatment of Hunter Syndrome in China (Press)
  • PRIME status for ProQR’s sepofarsen (PharmaLetter-$)
Medical Devices
  • US FDA recognizes AAMI/UL 2800 standard for medical device interoperability (Emergo)
  • Will Silicon Valley Eclipse Minnesota as the Biggest Medtech Hub? (MDDI)
US: Assorted & Government
  • AGs Fire Back After Pharma Bid To End Price-Fixing Claims (Law360-$)
  • Is ‘Competitive Licensing’ Proposed In HR 1046 Practical For Lowering Drug Prices? (Health Affairs)
  • A small group of patients account for a whole lot of spending (Axios)
  • Changes to NIH Requirements Regarding Proposed Human Fetal Tissue Research (NIH)
  • Lawmakers press Sharpless to bring stem cell companies into line (BioCentury)
  • Lethal Injection Drugs' Efficacy And Availability For Federal Executions (NPR)
  • Boston Scientific On Hook For $275M Merger, Chancery Told (Law360-$)
  • Meet The Top Attys In Gilead's 'No Generics' Antitrust Rumble (Law360-$)
  • As Bernie Sanders neared, Canadian officials were urged not to allow U.S. to import medicines (STAT)
  • Déjà vu all over again: Another year passes without approval of new suppliers of marijuana for research (STAT)
  • Kamala Harris Releases 'Medicare For All' Plan With A Role For Private Insurers (NPR)
Upcoming Meetings & Events Europe
  • Russia’s Biocad launching anti-psoriatic drugs production (PharmaLetter-$)
  • EMA’s Draft Guideline on Drug-Device Combinations Sheds Needed Light on Expectations for Device Assessment (IPQ)
  • Swissmedic laboratory publishes updated test method for nitrosamines in sartans (Swissmedic)
  • Supply problems with total parenteral nutrition (TPN) bags – Calea UK/Fresenius Kabi site in Runcorn, Cheshire (MHRA)
Asia
  • Taiho turns to incubation (BioCentury)
  • Takeda's deals paint a picture of a turnaround in action (BioCentury)
  • Indonesia to Shorten Review Period for Japan-Approved Drugs (PharmaJapan)
India
  • Cipla seeks favourable policy for domestic pharma cos, ease of doing biz (Economic Times)
  • Indian excipient industry needs to adopt global harmonised standards for patient safety (Pharmabiz)
  • Indian pharma sees US FDA's revised norms on REMS a step in right direction (Pharmabiz)
  • India’s clinical research efforts make in-roads for joint new drug discoveries: Malavika Kaura Saxena (Pharmabiz)
  • Government of India announces free testing, treatment for hepatitis B and C ahead of World Hepatitis Day on July 28 (Pharmabiz)
  • DoP rejects Mylan's review application against fixation of retail prices of TAF 25mg tablets & TAF 25mg+emtricitabine 200mg tablets (Pharmabiz)
  • Health ministry issues draft national guidelines for gene therapy product development (Pharmabiz)
Canada
  • Agile regulations for advanced therapeutic products and clinical trials (Health Canada)
  • Summary Safety Review - Surgical mesh products made from non-absorbable synthetic (polypropylene) material that are used for the transvaginal repair of pelvic organ prolapse (POP). – (Health Canada)
  • Notice: Revisions to the Guidance Document: Management of Drug Submissions and Applications (Health Canada)
General Health & Other Interesting Articles
  • US records 16 new measles cases as outbreak shows signs of slowing (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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