Regulatory Recon: FDA Approves First Strattera Generics; UK’s NICE Backs Keytruda (31 May 2017)

Posted 31 May 2017 By Zachary Brennan

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Welcome to Regulatory Recon, a daily regulatory news and intelligence briefing.

In Focus: US                                          

  • E&C User Fee Markup Delayed Over Off-Label Communication (Politico)
  • Amgen Sues FDA After Pediatric Exclusivity Denied for Sensipar (FDA Law Blog) (Life Sciences IPR) (GEN)
  • FDA approves first generic Strattera for the treatment of ADHD (FDA)
  • Leaked regulation: Trump plans to roll back Obamacare birth control mandate (Vox)
  • Ryan appoints controversial cancer doctor to HHS committee (Politico)
  • Prepping for ASCO? Investor Brad Loncar offers his own breakdown of what to watch for (Endpoints)
  • On ASCO’s Eve, Experts Fret Over Backlash to Cancer Combo Frenzy (Xconomy)
  • Cancer meeting to provide clues on future immunotherapy combos (Reuters)
  • First Cycle ANDA Approvals – Fact, Fiction, or Aspiration? (Lachman Consultants)
  • BIO statement on Supreme Court Ruling in Impression Products v. Lexmark (BIO) (PatentDocs)

In Focus: International

  • EMA relocation: Paris, Copenhagen and Stockholm at the top (Londra Italia) (PharmaLetter-$)
  • Trials of embryonic stem cells to launch in China (Nature)
  • Long-acting insulin price concerns challenge WHO proposal (In-PharmaTechnologist)
  • NICE backs Keytruda for first and second-line use (PharmaTimes) (PharmaPhorum)
  • Pfizer wins EU approval for MenB vaccine Trumenba (PMLive) (FierceBiotech)
  • Lilly, OrbiMed back China cancer upstart InventisBio in $19M series B (FierceBiotech)
  • Exclusive: Mallinckrodt explores sale of generic drugs business – sources (Reuters)
  • Sandoz edges closer to European market with Humira and Remicade biosimilars (PharmaLetter-$)
  • MSD allays Irish fears with €280m expansion investment (Pharmafile)
  • MSF fears some provisions in India-EFTA trade talks will erode India’s ability to supply generic drugs across developing world (PharmaBiz)
  • Array adds Ono as Japanese partner for MEK/BRAF combo (FierceBiotech)
  • South Korea’s Celltrion initiates biosimilar clinical trials in China (BioWorld)
  • Health Canada to Fully Implement ICH GCP Addendum in 2018 (Focus)
  • Powerful New Ebola Vaccine Heads To Congo To Help Stop Outbreak (NPR)
  • Regenerative medicine Ortho-ACI Included on the Australian Register of Therapeutic Goods (Press)

Pharmaceuticals and Biotechnology

  • CRISPR may not be as foolproof as earlier believed – gene editing tech leads to unwanted mutations (Nature) (Stat-$)
  • Cancer Drugs: Innovation ‘Blackmail’ Leads To Unaffordable Prices, Delinkage Needed, Speakers Say (IP-Watch)
  • Prototype converts digital data into drugs and biological materials (San Diego Union-Tribune)
  • Antibiotic Progress – And Not a Moment Too Soon (In the Pipeline)
  • $420M fund comes to LYFE, with plans for a trans-Pacific investment strategy introducing US biotechs to China (Endpoints)
  • Baxter and Mayo Clinic Launch Research and Development Collaboration to Transform Patient Care (Press)
  • Akari CEO quits after probe uncovers dodgy data release (FierceBiotech)
  • Protagonist Therapeutics Inks License Pact With Johnson & Johnson's Janssen (TheStreet)
  • Pfizer Seeks 6-Year Clock, Not 2, In Tossed $8M Tax Suit (Law360-$)
  • AstraZeneca puts Brilinta, Bydureon on pay-for-performance bandwagon with Harvard Pilgrim deals (FiercePharma)
  • RNA Specialist Arcturus Therapeutics Gets $3M R&D Grant for CF Drug (Xconomy)

Pharmaceuticals and Biotechnology: Study Results, Filings and Designations

  • Teva's migraine drug clears late-stage study (Reuters)
  • Pfizer Announces Acceptance of Regulatory Submissions by U.S. FDA and EMA for SUTENT (sunitinib) for Adjuvant Treatment of Adult Patients at High Risk of Recurrent Renal Cell Carcinoma After Surgery (Press)
  • FDA Grants Breakthrough Therapy Designation for Alnylam’s Givosiran for the Prophylaxis of Attacks in Patients with Acute Hepatic Porphyria (Press)
  • Novel Drug Promising in Pre-treated Metastatic NSCLC (MedPage Today)
  • Ralexar Therapeutics Initiates Phase 2b Study of ALX-101 in Patients with Atopic Dermatitis (Press)
  • Association of Prescription Drug Price Rebates in Medicare Part D With Patient Out-of-Pocket and Federal Spending (JAMA) (Kaiser Health News)
  • Novartis isn’t messing around with CAR-T, and it has a promising next-gen therapy to help prove it (Endpoints)
  • Gilead racing to FDA with a new HIV cocktail boasting megablockbuster potential (Endpoints)
  • Another old, cheap generic is being prepped for an FDA application — made over into a ‘new’ drug for ADHD and narcolepsy (Endpoints) (Reuters)

Medical Devices

  • Court Documents Shed Light on Theranos Board’s Response to Crisis (WSJ-$)
  • 3D printing could make bionic skin possible: Here’s how (Medical Design & Outsourcing)
  • Medtronic launches opioid-induced respiratory depression study (Mass Device)

US: Assorted and Government

  • New Maryland Law to Restrict Generic Drug Price Increases (Focus)
  • California considers drug cost transparency bill (Sacramento Bee)

Upcoming Meetings and Events               

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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