Regulatory Focus™ > News Articles > Regulatory Recon: Alexion CEO, CFO Step Down; Lonza in Talks to Buy Capsugel (12 December 2016)

Regulatory Recon: Alexion CEO, CFO Step Down Lonza in Talks to Buy Capsugel (12 December 2016)

Posted 12 December 2016 | By Michael Mezher 

Regulatory Recon: Alexion CEO, CFO Step Down Lonza in Talks to Buy Capsugel (12 December 2016)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Missed yesterday's Recon? Read it here.

In Focus: US

  • Wary Drug Makers Move to Fend Off Further Attacks Under Donald Trump (NYTimes)
  • Sanofi to cut 20 percent of its US diabetes sales and marketing staffs (STAT) (Fierce) (GEN)
  • Seattle Genetics chalks up first clinical trial success in solid tumors (Fierce) (Press)
  • Lives and Profits in the Balance: The High Stakes of Medical Patents (NYTimes)
  • Public Health under the Trump Administration (Harvard Bill of Health)
  • How Doctors Could Thwart Health-Care Reform (The New Yorker)
  • Price Poised To Protect Doctors' Interests At HHS (KHN)
  • WHO urges Trump to expand Obamacare, ensure healthcare for all (Reuters)
  • Watson and Pfizer (In The Pipeline)
  • US federal agencies pledge up to $1.1B for Emergent Biosolutions' anthrax vaccine (BioWorld)
  • The Cancer Lottery (MIT Technology Review)
  • Former Google Ventures CEO Bill Maris has decided not to go ahead with a new $230 million health care fund (Recode)
  • Congress Avoids FDA Shutdown in Late-Night Session (FDANews-$)
  • Companies Producing Drugs Only for INDs Exempt From FDA Registration (Focus)
  • Defeating cancer was once a 'war'; now it's a 'moonshot' (Washington Post)
  • Psoriasis Drug Valuation By ICER May Undercut Routine Step Therapy (Pink Sheet-$)
  • Alexion Names New CEO and CFO After Company's Leadership Leaves (WSJ) (Forbes)
  • CA Congressman Seeks More FDA Outreach for Biotech Start-Ups (Focus)
  • Medical Device Performance Goals: FDA Offers a Quarterly Update (Focus)
  • Seeking Profit and Investors, Rogue Lab Moves Into Small Hospitals (CardioBrief)
  • Generic copy of Roche flu pill Tamiflu hits US market (Reuters) (Economic Times)
  • Novartis/Ophthotech eye drug fails in nAMD trials (PharmaTimes) (Fierce) (Press)
  • US priority review for AZ' bladder cancer drug (PharmaTimes) (Reuters)
  • FDA's CDER Lays Out Rules for Public-Private Partnerships (Focus)
  • Spanish Drugmaker Sued for Off-Label Promotion of Thrombate III (FDANews-$)
  • CDER's Office of Biotechnology Products Sheds Light on Biosimilar CMC Challenges and Solutions (IPQ)

In Focus: International

  • Bayer, Versant invest $225 million in biotech venture (Reuters) (WSJ) (Press)
  • Achaogen soars, speeding top antibiotic to FDA/EMA after PhIII scores positive results (Endpoints) (Reuters)
  • Exclusive: Lonza says in talks to buy Capsugel; deal could top $5 billion (Reuters) (WSJ)
  • CFDA Releases Draft Classification Catalogue of Medical Devices (Inside Medical Devices)
  • EMA Revises Clinical Data Publication Guidance, Updates on Program (Focus)
  • Novartis eye drug franchise hit by failed Fovista studies (Reuters)
  • The TPP Is Dead. Long Live Free Trade. (Pink Sheet-$)
  • Health minister: Drugs pricing will top Malta's EU presidency (EurActiv)
  • Bioinvent back to drawing board as it pulls trial of lead drug for myeloma (Fierce) (Press)
  • Turkey Adopts New Investment Incentives But Pharma Wary (SCRIP-$)
  • India needs to invest more in public healthcare: WHO (Economic Times)
  • Could Pfizer's record fine for unfair prices change the industry's practices? (The Guardian)
  • Brexit: What Can The Life Sciences Industry Do About It? (SCRIP-$)
  • UK biotech group raises £100m to sell DNA-reading tools in Asia (Financial Times)
  • What's next for Medtech in the EU, post-Brexit? (MassDevice)
  • Astellas Announces Transfer of Qutenza to Grünenthal (Press)
  • French women file complaints over complications with Bayer's Essure (MassDevice) (Reuters)
  • EMA defends Adaptive Pathways (BioCentury)

US: Pharmaceuticals & Biotechnology

  • Puerto Rico's Biopharma Startups (SCRIP-$)
  • Patient Recruitment: Clinical Research's "White Whale"? (Pivotal Financial Consulting)
  • James Gilman, retired Army major general, to head troubled NIH clinical center (Washington Post)
  • AZ, Lilly to co-develop selective amyloid mAb (BioCentury)
  • Effective Dec 1, Pharmacies, Prescribers, and Wholesalers Must Report Gabapentin to Ohio Automated Rx Reporting System (National Law Review)
  • How Much Hope Is There For Alzheimer's Drugs? (Forbes)
  • Rx For Industry: Key Provisions Of The 21st Century Cures Act (SCRIP-$)
  • Acting on the potential of action potentials: will bioelectronic medicines be the next biologics? (Pharmaceutical Journal)
  • FDA Denies Adapt Pharma's Petition for Higher Standards to Approve Naloxone Generics (FDANews-$)
  • Donor Risk Assessment Questionnaire for the Food and Drug Administration/National Heart, Lung, and Blood Institute-Sponsored Transfusion-Transmissible Infections Monitoring System--Risk Factor Elicitation (FDA)
  • DNA-encoded chemistry: enabling the deeper sampling of chemical space (Nature)
  • Big price hikes seen in drug that prevents overdose deaths (Reuters)
  • NIHR partners with AstraZeneca on asthma study (PharmaTimes)
  • Roche's Genentech taps A-lister Morgan Freeman for cancer PSA (Fierce)
  • BMS' Opdivo jumps back into pharma's top 3 TV ad spenders for November (Fierce)
  • The Rise of Biosimilars (Pharmaceutical Manufacturing)
  • Therapeutic Progress Amid Political Turbulence: Could 2017 Be Pharma's Year? (SCRIP-$)
  • Scrip 100: R&D Paths Of Top 50 Pharma (SCRIP-$)
  • Scrip 100: The Architecture Of A Top Heavy Industry (SCRIP-$)
  • FDA's NDA And BLA Approvals: Tigecycline, Isopto (Pink Sheet-$)

US: Pharmaceuticals and Biotechnology: Clinical Study Results, Filings & Designations

  • Synergy Pharma's irritable bowel drug succeeds in key study (Reuters)
  • Eisai Presents Latest Data On BACE Inhibitor Elenbecestat(E2609) At 9th Clinical Trials On Alzheimer's Disease (Press)
  • Interim Analysis Of Phase Ib/II Study Of Eribulin and Pembrolizumab Combination Regimen In Metastatic Triple Negative Breast Cancer Presented At San Antonio Breast Cancer Symposium (Press)
  • C2N Diagnostics Reports Phase 1 Study Results of C2N-8E12 (ABBV-8E12) – Anti-Tau Antibody – in Subjects with Progressive Supranuclear Palsy (Press)
  • FDA Clears Lyme Vaccine Candidate for Clinical Testing (MPR)
  • Priority Review for durvalumab in bladder cancer (BioCentury)
  • AXON's Alzheimer Tau Vaccine Phase 1 Study Results Published in Lancet Neurology (Press)
  • Interim Results from Phase 1b/2 Study Evaluating the Combination of Merck's KEYTRUDA® (pembrolizumab) and Eisai's HALAVEN® (eribulin mesylate) Injection in Metastatic Triple-Negative Breast Cancer Presented at 2016 SABCS (Press)
  • Cancer Targeted Technology Commences Phase I Clinical Trial of CTT1057, a Diagnostic Imaging Agent for Prostate Cancer (Press)
  • Galderma Announces FDA Approval of Restylane® Refyne and Restylane® Defyne Dermal Fillers for Treatment of "Laugh Lines" (Press)

US: Medical Devices

  • 2016 FDA Guidance Documents You Should Know (MDDI)
  • Medical Device Reading List (December 11, 2016) (Biotech Due Diligence)
  • PMA Monthly approvals from 11/1/2016 to 11/30/2016 (FDA)
  • Centurion Recalls Multi-Med Single Lumen Catheters due to Excess Material that May Split or Separate (FDA 1, 2)
  • Scalp cooling device helps prevent hair loss from chemo (Reuters)

US: Assorted & Government

  • Implied Preemption and Monograph Drugs (Drug and Device Law)
  • PTAB Agrees To Review Allergan Restasis Patents (Law360-$) (Drug Delivery)
  • FTC Says Boehringer Should Cough Up Pay-For-Delay Docs (Law360-$)
  • Five Quick Ways A New HHS Secretary Could Change The Course Of Health Policy (KHN)
  • While Paul Ryan Plots Obamacare Fix, Insurers Want 'Transition' Money (Forbes)
  • In Antitrust Trial, Justice Department Questions Aetna-Humana Asset Sale Plan (WSJ)
  • Pharmacy Execs Want Separate Trials Over Deadly Outbreak (Law360-$)
  • Sanofi Can't Enforce Deal It Broke In $20M Suit, Elorac Says (Law360-$)
  • Prescription Drug Labels: Actions Needed To Increase Awareness Of Best Practices For Accessible Labels For Individuals Who Are Blind Or Visually Impaired (GAO)
  • Medicare Value-Based Payment Models: Participation Challenges and Available Assistance for Small and Rural Practices (GAO)
  • FDA takes action against four tobacco manufacturers for illegal sales of flavored cigarettes labeled as little cigars or cigars (FDA)

Upcoming Meetings & Events

Europe

  • Eric Cornut appointed Interim Director General as Richard Bergström leaves EFPIA (EFPIA)
  • Robert LaCaze to be Executive Vice President of New Oncology Strategic Business Unit at Pharmaceuticals Division of Bayer (Press)
  • Final flash report from the Plenary Meeting of the Health Security Committee November 2016, Senningen/Luxembourg (EC)
  • Germany's securPharm prepares for hospital pilot (Securing Industry)
  • Recommendations for the implementation of the exemptions to the labelling and package leaflet obligations in the centralised procedure (EMA)
  • Committee for Medicinal Products for Veterinary Use (CVMP) meeting 6-8 December 2016 (EMA)

India

  • Indian drug companies bet on global M&As in growth pursuit: Moody's (Economic Times)
  • Sun Pharma, Moebius Medical to develop osteoarthritis pain product (Economic Times)
  • Alkem gets 3 FDA observations post Ankleshwar unit inspection (Economic Times)
  • India needs $18 billion to win battle against malaria (Economic Times)

Canada

  • Notice – Final Release: Part I – Health Professional Information and Part II – Scientific Information of the Guidance Document – Product Monograph (Health Canada)

Zika

  • Texas reports four more cases of Zika spread by local mosquitoes (Reuters)
  • Microcephaly quadrupled in Colombia this year due to Zika: report (Reuters)
  • CDC updates Zika guidance for South Miami Beach (FL) area (CDC)
  • Evidence that Microcephaly Risk is Highest among Pregnant Women Infected Early in Pregnancy (CDC)

Other International

  • New WHO data portal to help track progress towards universal health coverage (WHO)
  • WHO commits to source drugs and vaccines from 'green' suppliers (InPharmaTechnologist)

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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