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Kodiak sells Baker Bros. royalty on net sales of KSI301
Published: 6 Dec 2019 | 0:40 UTC

Ophthalmic-focused Kodiak Sciences Inc. entered a royalty agreement with Baker Bros. Advisors involving Kodiak’s KSI301.

Venclose gets $27mm via Series C round
Published: 6 Dec 2019 | 0:40 UTC

Venclose Inc. raised $27mm in its Series C financing round led by Ally Bridge Group.

Amgen, Hummingbird Bio team up in potential $1.2bn multi-target collaboration
Published: 6 Dec 2019 | 0:40 UTC

Hummingbird Bioscience and Amgen Inc. are teaming up in a multi-target collaboration.

Inventiva launches with assets from Abbott subsidiary
Published: 6 Dec 2019 | 0:40 UTC

Inventiva Pharma has launched with assets from Laboratoires Fournier (part of Abbott’s Solvay). The assets include laboratories and equipment and a 230k molecule library.

Kodiak Sciences nets $259.4mm via FOPO
Published: 6 Dec 2019 | 0:40 UTC

Ophthalmic-focused Kodiak Sciences Inc. netted $295.4mm in a follow-on offering of 6mm common shares at $46 each. The company will use some of the funds to move its KSI301 towards the BLA filing in retinal vein occlusion and for sBLA submissions (expected in 2022) for wet age-related macular degeneration, diabetic macular edema (DME), and possibly diabetic retinopathy without DME. Additional funds will support development of additional pipeline candidates including KSI501 for DME and uveitis. Just one day prior to the offering, Kodiak sold Baker Bros. a capped 4.5% royalty on net sales of KSI301 in exchange for $225mm.

The J. M. Smucker Company Issues Voluntary Recall of  Specific Lots of Special Kitty® Wet, Canned Cat Food Due to Health Concerns
Published: 5 Dec 2019 | 23:20 UTC

The J. M. Smucker Company today announced a voluntary recall of specific lots of Special Kitty® wet, canned cat food due to health concerns potentially associated with ingredients believed to not meet the Company’s quality and safety standards.

Regulators Target Diabetes Drug Metformin for NDMA Contamination
Published: 5 Dec 2019 | 23:13 UTC

Healthcare regulators have set their sights on type 2 diabetes drug metformin to see if it contains unsafe amounts of N-nitrosodimethylamine (NDMA).

FDA Approves First Gilenya Generics
Published: 5 Dec 2019 | 23:12 UTC

Novartis’ blockbuster multiple sclerosis drug Gilenya (fingolimod) may soon face generic competitors in the U.S., following three FDA approvals.

Pelosi Announces H.R. 3 Vote Next Week
Published: 5 Dec 2019 | 23:12 UTC

House Speaker Nancy Pelosi announced yesterday that drug pricing measure H.R. 3 is headed to a House floor vote next week, where it is expected to pass. But because there is no Senate companion measure, there is unlikely to be final legislation on drug pricing this year.

CDER Recaps New Drug Approvals in 2019, Looks Ahead to 2020
Published: 5 Dec 2019 | 23:11 UTC

The FDA continued to lead the world in new molecular entity approvals in fiscal year 2019, according to a senior official in the Office of New Drugs.

FDA Approves First Generics of Gilenya
Published: 5 Dec 2019 | 22:12 UTC

December 05, 2019 -- The U.S. Food and Drug Administration has approved three applications for first generics of Gilenya (fingolimod) capsules for the treatment of relapsing forms of multiple sclerosis (MS) in adult patients. “Approving safe...

PharmaSwiss Recalls Emerade Adrenaline Pens
Published: 5 Dec 2019 | 22:09 UTC

The UK’s Medicines and Healthcare products Regulatory Agency advised healthcare professionals to quarantine all remaining stock and return it to the supplier.

Biogen divulges more data on Alzheimer’s trials
Published: 5 Dec 2019 | 19:14 UTC

Biotech’s shares fluctuate as it tries to win over sceptics of aducanumab

Annual Reported Measles Incidence Dropped From 2000 to 2018
Published: 5 Dec 2019 | 19:00 UTC

THURSDAY, Dec. 5, 2019 -- The annual reported measles incidence decreased from 2000 to 2018, but the number of cases increased from 2016 to 2018, according to research published in the Dec. 6 issue of the U.S. Centers for Disease Control and...

Nassau Candy Distributors Issues Allergy Alert on Undeclared Milk Allergen in Nancy Adams, Dark Chocolate Graham Crackers
Published: 5 Dec 2019 | 16:53 UTC

Nassau Candy Distributors of Hicksville, NY is recalling two lots of 7.5 OZ (212g) Nancy Adams, Dark Chocolate Graham Crackers because they may contain undeclared milk allergens.

Series D brings in $80.25mm for Impulse Dynamics
Published: 5 Dec 2019 | 0:40 UTC

Cardiovascular device maker Impulse Dynamics raised $80.25mm in its Series D financing led by Amzak Health Investors, which was joined by other first-time backers Wellington Management, Kennedy Lewis Investment Management, Acorn Biosciences, Minth Holdings, Zoll Medical, Abiomed, an undisclosed corporate investor, and Impulse Dynamics’ CEO and CFO. The company will use the proceeds for US commercialization of its Optimizer implantable smart system, which uses cardiac contractility modulation (CCM) technology to treat chronic heart failure.

US Pharmaceutical Industry Continues to Shine According to CPhI 2019 Annual Report
Published: 5 Dec 2019 | 0:00 UTC

Survey Results Highlight Continuing Strength of US Sector Along with Advances by Emerging Market Competitors

Cytokinetics Announces New Results Presented at the International Symposium on ALS/MNDSubgroup Analyses of FORTITUDE-ALS on Effects of Reldesemtiv with and without Concomitant Radicava® (edaravone) or Rilutek® (riluzole)
Published: 5 Dec 2019 | 0:00 UTC

The majority of patients received riluzole alone, 4.2% were receiving edaravone alone, and 20.6% were receiving both.

PANTHERx Adds Another Quarter of #1 Patient Satisfaction Results to Impressive History of National Recognitions
Published: 5 Dec 2019 | 0:00 UTC

For the third quarter of 2019, PANTHERx obtained the highest Net Promoter Score (NPS) among all specialty pharmacies surveyed including retail, hospital/health system, PBM/payer, and independent specialty pharmacies.

NHA's PharmaSeer Math™ Prepares Pharmacy Technicians to Master Calculations Used in Pharmacy Practice, to Reduce Dosage Errors
Published: 5 Dec 2019 | 0:00 UTC

National Healthcareer Association recently announced the launch of PharmaSeer Math™, a new product that prepares current and future pharmacy technicians with the skills and confidence to master calculations used across all pharmacy settings.

Netsmart Earns 5th Consecutive Top Post-Acute Technology Vendor Ranking by Black Book Research
Published: 5 Dec 2019 | 0:00 UTC

Netsmart announced it has been recognized as the #1 post-acute technology platform by Black Book Research (Black Book) for the fifth year in a row

American BriVision Initiates Phase II Part I Clinical Trial for ABV-1505 in Adult Attention-Deficit Hyperactivity Disorder (ADHD)
Published: 5 Dec 2019 | 0:00 UTC

PDC-1421, the active ingredient of ABV-1505, is being expanded into adult ADHD trials following encouraging Phase II trial results in major depressive disorder

VivaLnk Earns CE Mark for Multi-Vital Wearable Sensor and SDK
Published: 4 Dec 2019 | 18:59 UTC

The reusable sensor patch weighs 7.5 grams.

Nanomix’s POC Diagnostic for Serious Infections Gains CE Mark
Published: 4 Dec 2019 | 18:56 UTC

The panel is designed to quickly detect life-threatening infections like sepsis and bacteremia.

Trump administration willing to drop USMCA pharma provisions
Published: 4 Dec 2019 | 7:09 UTC

Bid to win support from Democrats in deal seen as template for future negotiations

Astellas pays $3bn in cash for Audentes
Published: 4 Dec 2019 | 0:40 UTC

Astellas Pharma Inc. is paying $60 per share (a 112% premium) in cash to acquire seven-year-old gene therapy firm Audentes Therapeutics Inc. The deal has a total equity value of $3bn.

FDA Approves Genentech’s Tecentriq Plus Chemotherapy (Abraxane and Carboplatin) for The Initial Treatment of Metastatic Non-Squamous Non-Small Cell Lung Cancer
Published: 3 Dec 2019 | 20:12 UTC

South San Francisco, CA -- December 3, 2019 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) approved Tecentriq (atezolizumab) in combination with chemotherapy...

Hogan Lovells obtains dismissal of all remaining charges against former New York State Assemblyman
Published: 3 Dec 2019 | 0:00 UTC

2 December 2019 – A New York State Supreme Court judge in Manhattan has dismissed all remaining charges against former New York State Assemblyman Alec Brook-Krasny in a long-running...

Coloplast Pulls Ureteral Stent Kits Over ‘Packaging Anomaly’
Published: 2 Dec 2019 | 21:51 UTC

All potentially affected inventories were placed on hold.

FDA Approves RediTrex (methotrexate) for Rheumatoid Arthritis, Juvenile Idiopathic Arthritis, and Psoriasis
Published: 2 Dec 2019 | 20:12 UTC

NASHVILLE, Tenn., Dec. 2, 2019 /PRNewswire/ -- Cumberland Pharmaceuticals Inc. (NASDAQ: CPIX), a specialty pharmaceutical company, today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for RediTrex, its new...

UPDATE: Increased Rate of Mortality in Patients Receiving Abiomed Impella RP System - Letter to Health Care Providers
Published: 2 Dec 2019 | 5:00 UTC

The FDA is providing the most recent, interim post-approval study results for Abiomed's Impella RP System.

Asahi Kasei offers to buy Veloxis
Published: 28 Nov 2019 | 5:40 UTC

Asahi Kasei Corp. has offered to pay $0.88 (DKK6.00 each; a 5% premium) for publicly traded Veloxis Pharmaceuticals AS. The deal is valued at $1.31bn.

Rare disease diagnostics firm Centogene completes $52mm IPO on Nasdaq
Published: 26 Nov 2019 | 5:40 UTC

German biotech Centogene BV (rare disease diagnostics and biomarker discovery) netted $52mm in its initial public offering on Nasdaq of 4mm shares at $14, the low end of its anticipated $14-16 range.

B. Braun Medical Inc. Issues Voluntary Nationwide Recall of Twenty-Two (22) Lots of Blood Administration Sets, Due to Potential for Leakage at the Joint Between the Blood Filters and Tubing
Published: 26 Nov 2019 | 5:00 UTC

B. Braun Medical Inc. [B. Braun] initiated a voluntary recall of twenty-two (22) lots of Blood Administration Sets. B. Braun identified through complaints and internal discrepancies the potential for leakage at the joint between the blood filters and tubing of these blood administration sets.

Evofem Biosciences Resubmits New Drug Application to U.S. FDA for Amphora® for the Prevention of Pregnancy
Published: 26 Nov 2019 | 3:11 UTC

SAN DIEGO, Nov. 26, 2019 /PRNewswire/ -- Evofem Biosciences, Inc. (NASDAQ: EVFM), a clinical-stage biopharmaceutical company, today announced that it has resubmitted its New Drug Application (NDA) to the U.S. Food and Drug...

Zogenix Announces FDA Acceptance for Filing of New Drug Application and Priority Review for Fintepla for the Treatment of Dravet Syndrome
Published: 25 Nov 2019 | 2:11 UTC

EMERYVILLE, Calif., Nov. 25, 2019 (GLOBE NEWSWIRE) -- Zogenix, Inc. (NASDAQ: ZGNX), a global pharmaceutical company developing rare disease therapies, today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the...

Dare acquires Microchips to enhance contraceptive offerings
Published: 22 Nov 2019 | 5:40 UTC

Dare Bioscience Inc. acquired private Microchips Biotech Inc. (wireless implantable microchip drug delivery technology) in a stock transaction with the potential for earn-outs.

Antares, Idorsia team up to develop drug-device combo product for myocardial infarction
Published: 20 Nov 2019 | 5:40 UTC

Idorsia Pharmaceuticals Ltd. and Antares Pharma Inc. are teaming up to develop a drug-device product that delivers Idorsia’s selatogrel using Antares’ subcutaneous QuickShot auto-injector for adults with suspected acute myocardial infarction (AMI).

ICU Medical buys HD catheter infection-prevention device firm Pursuit Vascular for up to $125mm
Published: 20 Nov 2019 | 5:40 UTC

ICU Medical Inc. agreed to acquire privately held Pursuit Vascular Inc. (device to reduce catheter-related bloodstream infections (CRBSIs) in hemodialysis (HD) patients).

Exagen completes $53.9mm IPO, five years after first filing
Published: 19 Nov 2019 | 17:29 UTC

Exagen Diagnostics Inc. (autoimmune disease testing and therapeutic drug monitoring) netted $53.9mm through its initial public offering of 4.14mm common shares (including the overallotment) at $14. The company first filed for an IPO back in 2014, but never completed the process.

GAO Flags How a REMS May Slow Generics
Published: 15 Nov 2019 | 22:47 UTC

Generic drugmakers have acknowledged to the GAO that their inability to access samples of reference drugs because of distribution limitations under certain risk evaluation and mitigation strategies (REMS) delayed or discouraged them from developing generic drugs.

ICER Questions Cost-Effectiveness of Novo Nordisk’s Diabetes Drug Rybelsus
Published: 1 Nov 2019 | 22:11 UTC

The Institute for Clinical and Economic Review (ICER) has questioned the cost-effectiveness of Novo Nordisk’s recently approved Type 2 diabetes treatment Rybelsus (oral semaglutide) compared to alternatives.

Bryn licenses exclusive global rights to Aptar's bidose nasal delivery device
Published: 26 Oct 2019 | 3:40 UTC

Bryn Pharma LLC licensed exclusive global rights to use Aptar Pharma’s bidose (BDS) nasal device to deliver its epinephrine nasal spray BRYN-NDS1C.

Opko, BMS aim to develop Alzheimer’s blood test
Published: 23 Oct 2019 | 3:40 UTC

Opko Health Inc. (point-of-care and molecular diagnostics and vaccines) and Bristol-Myers Squibb Co. will nonexclusively collaborate on the further development of Opko’s Alzheimer’s disease blood test.

CellaVision pays SEK268mm for RAL Diagnostics
Published: 12 Oct 2019 | 3:40 UTC

CellaVision AB acquired privately held cellular imaging company RAL Diagnostics for SEK268mm ($29.8mm).

Takeda and Prometheus Biosciences enter IBD partnership
Published: 9 Oct 2019 | 3:40 UTC

Takeda Pharmaceutical Co. Ltd. penned an agreement with Prometheus Biosciences Inc. (formerly Precision IBD) for the discovery and development of up to three new therapies (and related companion diagnostics) for inflammatory bowel disease (IBD).

Curetis, OpGen merge
Published: 6 Sep 2019 | 3:40 UTC

Curetis NV and fellow public infectious disease-focused molecular diagnostics firm OpGen Inc. are reverse merging.

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