Regulatory Focus™ > News Articles > Regulatory Recon: AbbVie Ordered to Pay $150M in AndroGel Suit; Stada Board Accepts Bain, Cinven's L

Regulatory Recon: AbbVie Ordered to Pay $150M in AndroGel Suit Stada Board Accepts Bain, Cinven's Latest Takeover Offer (25 July 2017)

Posted 25 July 2017 | By Michael Mezher 

Regulatory Recon: AbbVie Ordered to Pay $150M in AndroGel Suit Stada Board Accepts Bain, Cinven's Latest Takeover Offer (25 July 2017)

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

In Focus: US

  • AbbVie Ordered to Pay $150 Million in AndroGel Lawsuit (WSJ) (Reuters) (Bloomberg) (Fierce)
  • Scope Maker Olympus Hit With $6.6 Million Verdict In Superbug Outbreak Case (KHN)
  • Merck: Keytruda trial comes up short in head and neck cancer, but FDA approval stays (STAT) (Endpoints) (Pharmafile) (Reuters) (Press)
  • Yes, we can lower sky-high drug prices — other countries have done it (Los Angeles Times)
  • Price Transparency In Medicine Faces Stiff Opposition — From Hospitals And Doctors (KHN)
  • Biogen lays out a plan to "streamline" ops, add $400M to fund neurosciences R&D, new deals (Endpoints) (STAT) (Financial Times) (Reuters)
  • Restructuring the pipeline, Eli Lilly says a baricitinib comeback in rheumatoid arthritis could take years (Endpoints) (Press)
  • Neuralstem's lead drug crumbles in PhII, adding to a litany of failures for depression drugs and blasting shares (Endpoints)
  • Adding 'right to try' to FDA user fee bill would undermine the agency's work (STAT)
  • PhRMA Comment on the FDA's Proposed Off-label Rule: The Rule of Law is the Best Medicine (Drug & Device Law)
  • Targeting a $5B brand, Samsung and Merck launch Remicade Biosimilar at 35% discount (Fierce)
  • BPCIA Questions Continue To Arise For Biosimilar Applicants (Law360-$)
  • Biologics: The Drugs Transforming Medicine (US News)
  • Distinctive Biotech Corporate Culture: Walk The Talk (LifeSciVC)
  • Dozens of US clinics sell unproven stem cell therapies for heart failure (Reuters)
  • NCI-COG Pediatric MATCH trial to test targeted drugs in childhood cancers (NIH) (BioCentury)

In Focus: International

  • Stada Accepts €4.1bn Bain/Cinven Bid (Financial Times) (NYTimes)
  • Sanofi Exec Defends Company's Vaccine Investment (NYTimes)
  • The Tasmanian Hep C Buyers' Club (NYTimes)
  • Roche, Emcure may end pact to make 2 blockbuster drugs (Economic Times)
  • China's distribution changes force major US company out (Pharmafile)
  • GlaxoSmithKline Names Former Walmart Exec as New CTO (The Street)
  • Britain Eases Blood Donation Rules for Gay and Bisexual Men (NBC)
  • Cellectis Wins EU Patent For CRISPR T Cell Therapies (BioCentury)

Pharmaceuticals & Biotechnology

  • FDA's Kopcha Says New Inspection Protocols May Never Be Disclosed (Pink Sheet-$)
  • Eagle Says FDA Misses PDUFA Goal Date on Heat Stroke Drug (Press)
  • In adolescents, oral Truvada and vaginal ring for HIV prevention are safe, acceptable (NIH)
  • Event – Abbvie's long shot at proving Rova-T doubters wrong (EP Vantage)
  • Lilly Reports Second-Quarter Results (Press)
  • Goldwater Institute EVP and attorney/bioethicist to debate Right to Try (MedCityNews)
  • Policy conditions make or break leaders in biopharmaceutical innovation: Preliminary results from the 2017 BCI Survey (PhRMA)
  • Introducing A New Series Of Health Affairs Policy Primers: Prescription Drug Pricing (Health Affairs Blog)
  • Samsung Biologics: Reducing COGS could double mammalian CMO use to 50% (BioPharmaReporter)
  • Google's parent company invested in a hot cancer-testing start-up and built it a dedicated lab (CNBC)
  • Riders on the storm: VenatoRx bags a $42M round to back antibiotics pipeline (Endpoints)
  • Lilly, J&J, AbbVie and WuXi help seed a regenerative medicine upstart (Endpoints)
  • Takeda and BioSurfaces Announce Joint Research Program to Explore Promising Devices to Treat Gastrointestinal Diseases (Press)
  • Alisha A. Alaimo Appointed SVP of Biogen's US Therapeutic Operations (Press)
  • Animal Drug User Fees and Fee Waivers and Reductions; Revised Guidance for Industry (FDA)

Pharmaceuticals and Biotechnology: Study Results, Filings and Designations

  • U.S. Food and Drug Administration Accepts Bristol-Myers Squibb's Applications for Opdivo (nivolumab) Four-Week Dosing Schedule Across All Approved Indications (Press)
  • FDA Grants Fast Track Designation to Flex Pharma's FLX-787 for the Treatment of Severe Muscle Cramps Associated with ALS (Press)
  • SHIONOGI'S FLU VACCINE PASSES PHASE III TEST (BioCentury)
  • Merck's Investigational NNRTI, Doravirine, Meets Primary Efficacy Endpoint of Non-Inferiority to Efavirenz, Both in Combination with Other Antiretroviral Agents, in Pivotal Phase 3 Trial for Treatment of HIV-1 Infection (Press)
  • Resverlogix Receives Approval Pathway from the FDA as to the Inclusion of USA Patients in the Phase 3 BETonMACE Trial (Press)
  • Janssen Announces Phase 3 Pivotal Study Results for Darunavir-Based Complete Treatment Regimen (Press)
  • Kadmon Announces Supplemental Interim Phase 2 Data of KD025 in Chronic Graft-Versus-Host Disease (Press)
  • NantKwest Announces Publication of Preclinical Data of haNK Cell Therapy in Combination with Checkpoint Inhibitor Avelumab Providing Strong Rationale for Advancement to Human Clinical Trials (Press)
  • Samumed Receives Orphan Drug Designation from FDA for SM04646 as a Treatment for Idiopathic Pulmonary Fibrosis (IPF) (Press)
  • Reata Gains As Bardoxolone Study Moves To Phase III (BioCentury)

Medical Devices

  • Ensuring the Security of Medical Devices with Dynamic Testing (MDDI)
  • Over-The-Counter Devices Hold Their Own Against Costly Hearing Aids (KHN)
  • DNA Logic Gets Much Faster (IEEE Spectrum)
  • Celgene adds Novocure's noninvasive brain cancer device to combo drug trial (Fierce)
  • AdvaMed protests FDA update to "intended use" language (MassDevice)
  • Johnson & Johnson rolls Pulsar Vascular, Neuravi into new Cerenovus neurovascular biz (MassDevice)
  • Arch Therapeutics submits FDA 510(k) for AC5 wound treatment gel (MassDevice)
  • Senseonics inks artificial pancreas deal with Roche, TypeZero Technologies (Drug Delivery)
  • Luminex Receives FDA Clearance for C. Diff Assay (GenomeWeb)

US: Assorted & Government

  • Democrats Accuse HHS of Using Improper Tactics in Health-Law Battle (WSJ)
  • FDA 'deeming rule' survives first court challenge (Washington Post)
  • Dodging $938M in damages, Amphastar prevails in Momenta, Sandoz patent fight (Fierce)
  • PTAB Life Sciences Report (Patent Docs)
  • United States v. Medistat RX LLC Consent Decree: FDA's Latest Enforcement Effort Related to Compounders and Title I of the Compounding Quality Act (FDA Law Blog)
  • Martin Shkreli will not testify at his securities fraud trial, 'pharma bro' reveals (CNBC)

Upcoming Meetings & Events

Europe

  • Revision: Guideline on strategies to identify and mitigate risks for first-in-human and early clinical trials with investigational medicinal products (EMA)
  • Chongquing Succeway made APIs in undeclared plant and faked records says ANSM (In-PharmaTechnologist)

Asia

  • WuXi's STA in five-year supply deal with Tesaro (PharmaLetter-$)

India

  • Follow notification on capping prices of stents: Health minister to hospitals (Economic Times)
  • Health ministry issues draft guidance document on "Essential principles for safety and performance of medical devices" (PharmaBiz)
  • Glenmark Pharma gets USFDA approval for skin cream generic (Economic Times)
  • Zydus Cadila gets USFDA nod for its ulcerative colitis drug (Economic Times)
  • ARPA wants DCGI to bring in new rule to add one more warning line on the labels of scheduled drugs (PharmaBiz)
  • Poor spend a fortune on even basic healthcare (Economic Times)

Canada

  • Data Extracts from the Canada Vigilance Adverse Reaction Online Database (Health Canada)
  • Health Canada Approves ADCETRIS® (Brentuximab Vedotin) for the Post-ASCT Consolidation Treatment of Patients with Hodgkin Lymphoma at Increased Risk of Relapse or Progression (Press)

Other International

  • Dengue outbreak kills 300 in Sri Lanka, hospitals at limit (Reuters)

General Health & Other Interesting Articles

  • How Kids See the World Depends a Lot on Genetics (NIH)
  • Stopping cholesterol-lowering drugs could be deadly (Reuters)
  • Slight drop in measles vaccinations could triple infections in US kids (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.

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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