Regulatory Focus™ > News Articles > Regulatory Recon: Celgene to Buy Impact Biomedicines for Up to $7B; Ablynx Rejects Novo's $3.1B Bid

Regulatory Recon: Celgene to Buy Impact Biomedicines for Up to $7B Ablynx Rejects Novo's $3.1B Bid (8 January 2018)

Posted 08 January 2018 | By Michael Mezher 

Regulatory Recon: Celgene to Buy Impact Biomedicines for Up to $7B Ablynx Rejects Novo's $3.1B Bid (8 January 2018)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

In Focus: US

  • $11 billion biotech binge fuels forecasts of 2018 M&A surge (Reuters) (Boston Globe)
  • Celgene to Buy Impact Biomedicines (WSJ) (STAT) (Endpoints) (Fierce) (Financial Times) (Press)
  • Good morning from JPM (Politico) (STAT)
  • JPM is like a biotech dating game, just ask these questions before hooking up (STAT)
  • Axovant shares blasted as premier drug proves worthless, second drug misses key goal (Endpoints) (STAT) (Reuters) (In the Pipeline)
  • Pfizer closing its neuroscience division and cutting 300 jobs (STAT) (Endpoints) (Reuters)
  • After resisting a push to the auction block, Acorda preps for a sale and shares shoot up — report (Endpoints) (CNBC)
  • Sanofi, Regeneron up the ante on PD-1 I/O program by a billion dollars (Endpoints) (Reuters)
  • Sanofi to market new hemophilia drug in deal with Alnylam (Reuters) (Endpoints)
  • CRISPR hits a snag: Our immune systems may attack the treatment (STAT)
  • Medical-Device Industry Boosts Efforts to Fight Excise Tax (WSJ)
  • Bristol-Myers sees $3 billion tax hit in fourth quarter 2017 (CNBC)
  • Humira's Best-Selling Drug Formula: Start at a High Price. Go Higher. (NYTimes)
  • Shire to separate ADHD drugs before possible spin-off, cuts 2020 target (Reuters)
  • Medical Research? Congress Cheers. Medical Care? Congress Brawls. (NYTimes)

In Focus: International

  • Novo Nordisk's $3.1 billion Ablynx bid rejected by Belgian biotech (Reuters) (Financial Times) (Endpoints) (Fierce) (Press)
  • UK in push to remain part of EU medicines agency after Brexit (Financial Times)
  • Drug Company Consortium To Sequence The Genes Of 500,000 Britons Over Next Two Years (Forbes) (WSJ) (Reuters) (MIT Technology Review)
  • EU Regulatory Reads, 2017: Are We Heading Toward A 2018 Crisis? (MedtechInsight-$)
  • Brexit to swallow £70m meant for developing cancer drugs, says GSK (The Guardian)
  • Track and Trace Systems Need Global Alignment, Regulators Urge (Pink Sheet-$)
  • Industry Underwhelmed By EMA Pediatrics Pharmacovigilance Guide Update Plans (Pink Sheet-$)
  • Teva inks $200M global licensing deal with migraine rival Alder (Endpoints)
  • New medical treatments becoming problematic (The Japan News)
  • German drugmaker Dermapharm plans March IPO (Reuters)
  • Hungary's Richter expects Esmya drug ruling in first half: CEO (Reuters)
  • Eight Chinese pharma firms may be blacklisted by India over quality issues (Economic Times)

Pharmaceuticals & Biotechnology

  • Happy New Year! Lasso Yourself Some FDA Data with the Agency's New Data Dashboard (FDA Law Blog)
  • Mother Alleges Biotech Firm Stole Data From Her Sick Children (Forbes)
  • Drug charity halts patient aid after U.S. health agency pulls approval (Reuters)
  • Pfizer Establishes New Partnering Model for Early-Stage Academic Research (Press)
  • Vertex's cystic fibrosis treatment makes it a hot company (Financial Times)
  • The PROs and cons of pushing patient centricity (Pharmafile)
  • US FDA Sets Records With Breakthrough Therapy, Priority Review Designations In 2017 (Pink Sheet-$)
  • Inspecting the Inspectors: What it Takes to Remain an MQSA Qualified Inspector (FDA)
  • Rational drug design: How far have we come? (EPR)
  • Adaptimmune Announces Two Manufacturing Achievements on Its way to Become the First Fully Integrated TCR T-cell Therapy Company (Press)
  • Deconstructing an opioid receptor could pave the way to safer painkillers (Fierce)
  • United We Stand Vs. Divide And Conquer: Pharma In The Age Of Trump (Pink Sheet-$)
  • FDA Removes Expired Drug Establishment Registrations and Uncertified Listings from its Database (Press)
  • Similarity margin for psoriasis biosimilars may be 'unacceptably wide' for some clinicians (Dermatology Times)
  • Perrigo hires Gerresheimer ex-boss Rohrhoff as new CEO (Reuters)
  • US FDA may inspect Sun Pharma's Halol site in February: Sources(Economic Times)
  • ADHD drug tied to heart defects in babies (Reuters)
  • Pernix lays off another 41 sales staffers as Treximet generics loom (Fierce)
  • Open science demystified (Novartis)
  • Organic dealmaker for drug discovery (Novartis)
  • Livongo and Lilly Collaborate on Real-World Diabetes Research (Press)
  • Editas Medicine Reports on Recent Progress and Announces "EM22" Five-year Goals at J.P. Morgan Healthcare Conference (Press)
  • 2018 Meeting Materials, Bone, Reproductive and Urologic Drugs Advisory Committee (FDA)

Pharmaceutical and Biotechnology: Study Results, Filings and Designations

  • Shire's Maribavir wins US breakthrough therapy designation (PMLive)
  • Acacia's PONV drug under US review (PharmaTimes)
  • FDA Accepts New Drug Applications for Merck's Doravirine, the Company's Investigational Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI), for Treatment of HIV-1 Infection (Press)
  • Novaliq Announces First Patient Enrolled in Its SEECASE Phase 2 Trial of NOV03 for the Treatment of Dry Eye Disease (Press)
  • Acceleron Announces Preliminary Results from Part 1 of the ACE-083 Phase 2 Trial in Patients with Facioscapulohumeral Dystrophy (Press)
  • Aimmune Therapeutics Announces 2018 Outlook, Including Upcoming Data from Pivotal Phase 3 PALISADE Trial of AR101 for Peanut Allergy (Press)
  • Revance Announces Interim Phase 2a Results for RT002 in Treating Plantar Fasciitis (Press)
  • Ra Pharmaceuticals Initiates Dosing in Phase 1b Pharmacokinetic Study Evaluating RA101495 SC in Patients with Renal Impairment (Press)
  • Successful Completion of Pre-clinical Safety Studies With MIV-818, Enabling Start of Phase I Clinical Studies in 2018 (Press)

Medical Devices

  • Delivering growth: M&A in medical technology (McKinsey)
  • Baxter Announces Agreement to Broaden Portfolio of Innovative Surgical Products (Press)
  • Roche and GE enter partnership to develop integrated digital diagnostics platform to improve oncology and critical care treatment (Press)
  • BioCardia files 2nd FDA IDE bid for CardiAMP chronic myocardial ischemia, refractory angina study (Drug Delivery)
  • Planmed Oy wins FDA nod for Clarity 2D digital mammography system (MassDevice)

US: Assorted & Government

  • How Trump's HHS nominee's drug company 'gamed' a patent (Politico)
  • Former CFO of Arthrocare Corporation Sentenced to Prison for Role in $750 Million Securities Fraud Scheme (DoJ)
  • Attorney General Sessions Applauds China for Restricting Two Fentanyl Precursors (DoJ)
  • Koch-backed groups launch 'Right to Try' campaign (The Hill)
  • Deaths of Despair or Drug Problems? (National Bureau of Economic Research)
  • Ensuring an Effective and Motivated Workforce (Alliance for a Stronger FDA)
  • A Baby Girl, Ready to Go Home, Is Still in the Hospital 400 Days Later (Bloomberg)
  • Trump asked 'Why can't Medicare simply cover everybody?' before pushing Obamacare repeal (CNBC)
  • In a Word – Incredible (Drug & Device Law)

Upcoming Meetings & Events

Europe

  • Happy New Medical Devices Year! – Halfway Point of MDR Transition (MedicalDevicesLegal)
  • UK Life Sciences firms struggle in post-Brexit war for EU talent (EPR)
  • New European Borderline and Classification Manual Published (Emergo)
  • Previous EU Guidance Wrong On Format Rule For Mutual Recognition Procedures (Pink Sheet-$)
  • 'Involve quality and safety in the discussion about medicines,' says Dutch regulator (PharmaLetter-$)
  • Final assessment report on MammaPrint® - Added value of using the gene expression signature test MammaPrint® for adjuvant chemotherapy decision-making in early breast cancer (EUnetHTA)

Asia

  • Announcement: Date of the 23rd AHWP Annual Meeting in 2018 (AHWP)

India

  • I​​ndia imported APIs worth Rs 18,372.54 crore in 2016-17 (Economic Times)
  • Medical Technology Association bats for tax breaks for R&D centres (Economic Times)
  • Orchid Pharma gets EIR from USFDA for its Chennai facility (Economic Times)

Canada

  • Summary Safety Review - AVONEX (interferon beta-1a) - Assessing the Potential Risk of an Inflammatory Disease that Affects One or More Organs (Sarcoidosis) (Health Canada)

Other International

  • Draft thirteenth general programme of work 2019–2023 (WHO)
  • Preliminary evaluation of the WHO global coordination mechanism on the prevention and control of noncommunicable diseases (WHO)
  • Brazil expects to be declared free of foot-and-mouth with vaccination (Reuters)
  • Zambia declares curfew in Lusaka slum struck by cholera (Reuters)
  • Death toll in South Africa listeria outbreak jumps to 61 (Reuters)

General Health

  • Marking 50 Years Since The First Adult Heart Transplant In The US (NPR)
  • Walks, not pills: Clinic gives hope to patients with chronic pain (NBC)
  • Patient Voices: Fibromyalgia (NYTimes)

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.

Need to contact the editor of Regulatory Reconnaissance? Find him on Twitter at @Michael_Mezher or send him an email at news@raps.org.

A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.


Categories: Recon, Regulatory News

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