Regulatory Focus™ > News Articles > 2019 > 12 > Recon: Early Readout Shows Promise for AZ, Daiichi Breast Cancer Drug; FDA Panel Votes Against Corre

Recon: Early Readout Shows Promise for AZ, Daiichi Breast Cancer Drug; FDA Panel Votes Against Correvio Heart Drug

Posted 11 December 2019 | By Michael Mezher 

Recon: Early Readout Shows Promise for AZ, Daiichi Breast Cancer Drug; FDA Panel Votes Against Correvio Heart Drug

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • Correvio suffers fresh blow as heart drug fails to win FDA panel backing (Reuters) (Endpoints)
  • Correvio Pharma to explore sale after FDA panel setback, shares plunge (Reuters)
  • Blood Tests Show Exposure to Ethylene Oxide (WebMD)
  • Pelosi brokers deal with liberals on drug pricing bill (Politico) (STAT)
  • Pelosi drug pricing plan would save $456 billion over 10 years: analysis (The Hill)
  • Investors fear Pelosi’s drug price plan will kill small biotech firms (CNBC)
  • How contaminants from prescription-drug factories pollute waterways (STAT)
  • Johnson & Johnson appeals Oklahoma judge's opioid ruling (AP)
  • FDA staff spotlight issue with one of Horizon's endpoints but notes efficacy for lead drug (Endpoints)
  • Supreme Court justices lean toward insurers on $12 billion Obamacare claims (Reuters)
In Focus: International
  • China’s Curing Cancer Faster and Cheaper Than Anywhere Else (Bloomberg)
  • AstraZeneca-Daiichi drug halts cancer for months in first readout (Reuters) (STAT) (Press)
  • EU expands scope of Vertex’ Kalydeco (PharmaTimes)
  • Singapore And Malaysia Test Joint Evaluation Of Generics (Pink Sheet-$)
  • Novartis still hasn't solved its CAR-T manufacturing issues (BioPharmaDive) (Outsourcing Pharma)
  • The Commission and the Council on the MDR state of affairs (MedicalDevicesLegal)
  • USMCA Drops Biologic Exclusivity Provisions for Mexico and Canada in Final Deal (Focus)
Pharmaceuticals & Biotechnology
  • In its largest fundraising effort to date, Omega Funds pulls in over $400 million (STAT) (Endpoints)
  • In tight Massachusetts job market, it’s relo for biotech and remote for tech hires (STAT)
  • 2019 biotech IPOs: party on (Nature)
  • Arguments on Drug Pricing (In the Pipeline)
  • Foreign Drug Inspections Decline as FDA Hiring Struggles Continue (Focus)
  • Sanofi’s sutimlimab set for filing in rare autoimmune anaemia next year (PMLive)
  • Amneal buying AvKare, drugmaker to the feds (Fierce) (Press)
  • The growing role of connected tech in medical research (Harvard Business School)
  • Flagship’s Cellarity Aims to Advance Cell Behavior-Based Therapeutics (Xconomy)
  • FDA Warns Two US Drugmakers Over GMP Deficiencies (Focus)
  • Afib Drug Gets a Chance to Exit Regulatory Limbo (Medpage)
  • Oral immunotherapy can be a game changer for many with food allergies (STAT)
  • Immunotherapy drug improves outcomes for some children with relapsed leukemia (NIH)
  • Fresh red blood cell transfusions do not help critically ill children more than older cells (NIH)
  • The (Possible) “Dark Side” of Gene Editing Technologies (Harvard Bill of Health)
  • Antibiotics manufacturing components can trigger adverse reactions. Standards help restore quality and trust. (USP)
  • US FDA Pushes Back Against Critics: Breakthrough Is Not A Drug 'Beauty Contest' (Pink Sheet-$)
  • UniQure, Pfizer updates hint at gene therapy potential in hemophilia B (BioPharmaDive)
  • Immune agonist antibodies face critical test (Nature)
  • Battered, cash hungry Intec feels the burn of Novartis rejection (Endpoints)
Pharmaceutical & Biotechnology: Study Results, Filings & Designations
  • GenSight Biologics reports findings from REALITY study and REVERSE-RESCUE analysis highlighting positive benefits from LUMEVOQ™ (GS010) compared to LHON natural history (Press)
  • Novartis announces FDA filing acceptance of Xolair® (omalizumab) for treatment of nasal polyps (Press)
  • Arrowhead Pharmaceuticals Files IND for Phase 1b Study of ARO-HIF2 for Treatment of Clear Cell Renal Cell Carcinoma (Press)
  • APHINITY six-year results strengthen evidence of clinical benefit with Roche’s Perjeta-based regimen (Press)
  • KalVista Pharma Eye Drug Partnered With Merck Flunks Phase 2 Test (Xconomy)
  • SABCS: MacroGenics' margetuximab posts OS gains in specific metastatic breast cancer patients (Fierce)
  • Little Leo Pharma enters the prize-fight ring with positive PhIII atopic dermatitis data. Now they just have to beat Dupixent (Endpoints) (Press)
  • Exicure Reports Activity of AST-008 in Patients with Merkel Cell Carcinoma and Will Enroll Patients in Phase 2 Study (Press)
  • BlackThorn Therapeutics Reports Data Supporting Phase 2 Development of KOR Antagonist, BTRX-335140, in Depression and Other CNS Disorders (Press)
  • With looming superbug crisis, Iterum misses in a key antibiotic trial — and its shares tumble (Endpoints)
  • CStone announces enrollment target reached in the global Phase III VOYAGER trial of avapritinib in Chinese patients with third-line GIST (Press)
  • Xeris Pharmaceuticals Announces Positive Topline Results From the In-clinic Stage of the Phase 2 Study of Its Developmental Ready-to-use (RTU) Glucagon in Patients at Risk of Postprandial Hypoglycemia Following Bariatric Surgery (Press)
  • Bristol-Myers shows off a low-profile AML contender it gained from Celgene buyout — and they’re taking it straight to the FDA (Endpoints)
  • Oncternal Therapeutics Announces Opening of Phase 1b Expansion Cohort of Clinical Trial of TK216, Targeted ETS Inhibitor, in Patients with Ewing Sarcoma (Press)
  • Seattle Genetics details positive OS and PFS data for tucatinib in breast cancer (Endpoints)
 Medical Devices
  • Google snaps up chief medical officer of health device maker AliveCor, weeks after buying Fitbit (CNBC)
  • What Sanofi’s withdrawal from diabetes tech tells us about digital health (STAT) (MedtechDive)
  • FDA names Beta Bionics' pancreas tech a breakthrough device (MedtechDive)
  • Report: EtO blood levels higher in Illinois neighbors of Medline sterilization plant (MassDevice)
  • FDA clears Cochlear piezoelectric hearing implant (MassDevice)
  • Biolase lands 510(k) for dental hygiene laser (MassDevice)
  • STAAR Surgical Announces FDA IDE Clinical Study Approval (Press)
US: Assorted & Government
  • MDL Judge Calls out Plaintiffs’ Counsel − Not Acting in Clients’ Best Interests (Drug & Device Law)
  • Justice Department Will Reportedly Review Google’s $2.1 Billion Fitbit Acquisition (Forbes)
  • White House Summons Feuding Health Officials for Counseling Session (NYTimes)
  • The IRS Sent a Letter to 3.9 Million People. It Saved Some of Their Lives. (NYTimes)
  • FDA's E-Cigarette Regulations Upheld By DC Circ. (Law360-$)
  • 3 Strategies To Manage Case Scope In ANDA Patent Litigation (Law360-$)
  • GLAAD Urges Facebook To Drop Law Firms' HIV Drug Ads (Law360-$)
  • Ex-Kite CEO Undermines Testimony Of Pharma Co.'s Founder (Law360-$)
  • States Demand Purdue Fight Opioid Crisis With 9-Point Plan (Law360-$)
  • Clinical Biopharma Sienna OK'd To Sell IP In Ch. 11 (Law360-$)
Upcoming Meetings & Events Europe
  • Recall of Medicina IV Luer Slip syringe (IVS03) batch number 19040303 (MDA/2019/043) (MHRA)
Asia
  • Asia Regulatory Roundup: Australia Runs out of EpiPen Jr Ahead of Release of Contaminated Batch (Focus)
Australia
  • Update to listed medicine ingredients in December 2019 (TGA)
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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