Medical Tidbits, Amgen’s First Biosimilar Marketing Authorization Application Submitted To European Medicines Agency For ABP 501

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Supported by Phase 3 Studies in Moderate-to-Severe Plaque Psoriasis and Moderate-to-Severe Rheumatoid Arthritis

THOUSAND OAKS, Calif., Nov. 25, 2015 /PRNewswire/ — Amgen (NASDAQ:AMGN) today announced the submission of a Biologics License Application (BLA) with the United States (U.S.) Food and Drug Administration (FDA) for ABP 501, a biosimilar candidate to Humira® (adalimumab). Amgen believes this submission is the first adalimumab biosimilar application submitted to the FDA and represents Amgen’s first BLA submission using the 351(k) biosimilar pathway. read more

European Medicines Agency Validates Gilead’s Marketing Application for Fixed-Dose Combination of Sofosbuvir/Velpatasvir for the Treatment of Hepatitis C

If Approved, SOF/VEL Would be the First All-Oral, Pan-Genotypic Single Tablet Regimen for Chronic HCV in Europe —

— SOF/VEL Granted an Accelerated Assessment by the European Medicines Agency —

FOSTER CITY, Calif.–(BUSINESS WIRE)–Dec. 4, 2015– Gilead Sciences, Inc. (Nasdaq:GILD) today announced that its Marketing Authorization Application (MAA) for an investigational, once-daily fixed-dose combination of the nucleotide analog polymerase inhibitor sofosbuvir (SOF) 400 mg and velpatasvir (VEL) 100 mg, an investigational pan-genotypic NS5A inhibitor, for the treatment of chronic hepatitis C virus (HCV) infection, has been fully validated and is now under assessment by the European Medicines Agency (EMA). The data included in the application, which was submitted on November 17, 2015, support the use of SOF/VEL among patients with genotype 1-6 HCV infection, including patients with compensated and decompensated cirrhosis. read more

Novo Nordisk files for regulatory approval of faster-acting insulin aspart in the EU for the treatment of type 1 and 2 diabetes

Bagsværd, Denmark, 4 December 2015 – Novo Nordisk today announced the submission to the European Medicines Agency of the Marketing Authorisation Application (MAA) for the approval of faster-acting insulin aspart. Faster-acting insulin aspart is a mealtime insulin for improved control of postprandial glucose excursions and has been developed for the treatment of people with type 1 and type 2 diabetes.

Novo Nordisk expects to file the new drug application for faster-acting insulin aspart to the US Food and Drug Administration before year-end 2015.  

The filing of faster-acting insulin aspart is based on the results from the ‘onset’ clinical trial programme which involved around 2,100 people with type 1 and 2 diabetes. In the onset programme, people treated with faster-acting insulin aspart achieved improvements in postprandial control versus NovoRapid® and an HbA1c reduction on par with NovoRapid®. For people with type 1 diabetes, faster-acting insulin aspart results from the double-blinded onset 1 trial showed statistically significantly greater HbA1c reduction when dosed at mealtime or similar HbA1c reduction when dosed 20 minutes after a meal compared to NovoRapid®. Across the onset trials, faster-acting insulin aspart had a safe and well tolerated profile, with the most common adverse event being hypoglycaemia, similar to the levels observed with NovoRapid® 

“With the regulatory filing of faster-acting insulin aspart, we take yet another step in helping people with diabetes improve their blood glucose control around meals,” said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk. “Onset 1 shows that faster-acting insulin aspart has the potential to offer improved postprandial glucose and either an additional reduction of HbA1c or added flexibility compared with NovoRapid®.”  

Novo Nordisk intends to make faster-acting insulin aspart available in the prefilled delivery device FlexTouch®.

Samsung Bioepis’ RENFLEXIS® Infliximab Biosimilar Receives Regulatory Approval in Korea

INCHEON, Korea–(EON: Enhanced Online News)–Samsung Bioepis Co., Ltd. today announced that Korea’s Ministry of Food and Drug Safety (MFDS) has approved RENFLEXIS® – a biosimilar version of Remicade® (infliximab), also known as SB2 – for the treatment of rheumatoid arthritis, ankylosing spondylitis, Crohn’s disease, pediatric Crohn’s disease, ulcerative colitis, pediatric ulcerative colitis, psoriatic arthritis and plaque psoriasis. This marks the second regulatory approval for Samsung Bioepis in Korea. The MFDS approved in September 2015 Samsung Bioepis’ BRENZYS®, a biosimilar version of Enbrel® (etanercept), also known as SB4.  read more

Frontline BioVentures to Form Strategic Partnership with Sinopharm Group Co., Ltd. (“Sinopharm”)

 Frontline BioVentures will provide Sino Health a rich pipeline of innovative products and cutting edge technologies through its network and portfolio companies while also providing seasoned investment expertise. Sinopharm will remain a key shareholder of Sino Health and continue to provide Sino Health with access to its distribution networks covering thousands of hospitals across China. read more

Cellectis Announces Conference Call to Discuss UCART19 Development Collaboration with Pfizer and Servier

PARIS–(EON: Enhanced Online News)–Cellectis (Alternext: ALCLS – Nasdaq: CLLS) will host a conference call with Pfizer Inc. (PFE) and Servier on Monday, December 7, 2015 at 8:00 a.m. Eastern Time to discuss their previously announced UCART19 development collaboration.

UCART19 is a TALEN® gene-edited allogeneic Chimeric Antigen Receptor T-Cell (CAR-T) immunotherapy developed by Cellectis. On November 19, 2015, Servier exercised its worldwide licensing option with Cellectis to UCART19 and entered into a global UCART19 license and collaboration agreement with Pfizer. read more

Trevena Announces FDA Grant of Fast Track Designation to Oliceridine (TRV130) for the Management of Moderate-to-Severe Acute Pain

KING OF PRUSSIA, Pa.–(BUSINESS WIRE)–Trevena, Inc. (NASDAQ: TRVN), a clinical stage biopharmaceutical company focused on the discovery and development of biased ligands targeting G protein coupled receptors, today announced that the United States Food and Drug Administration (FDA) has granted Fast Track designation to oliceridine (TRV130) for the management of moderate-to-severe acute pain. Oliceridine is being developed as a potential replacement for currently approved intravenous opioid analgesics. In a recently completed Phase 2 study in postoperative pain, oliceridine matched the analgesic efficacy of morphine with an improved safety and tolerability profile. Trevena expects to initiate Phase 3 development of oliceridine in the first quarter of 2016. read more

PROCEPT BioRobotics Announces First Patients Treated in Global IDE Clinical Trial for BPH  

REDWOOD SHORES, Calif., Dec. 3, 2015 /PRNewswire/ — PROCEPT BioRobotics, a medical device company developing a novel minimally invasive water ablation therapy to surgically treat prostate disease, announced that Peter Gilling, MD, of Urology Bay of Plenty, Tauranga, New Zealand, has treated the first patients in a global Phase III clinical study evaluating the safety and effectiveness of the AquaBeam® System as compared to the current standard of care, transurethral resection of the prostate, or TURP.   The AquaBeam System combines image guidance and robotics to deliver Aquablation, a waterjet ablation therapy that enables targeted, controlled, and heat-free removal of the tissue for the treatment of lower urinary tract symptoms caused by benign prostatic hyperplasia (BPH), a common prostate problem affecting more than 50% of men over 50 years in age.  read more

UCB reinforces its commitment to epilepsy research with a strong presence at the 2015 American Epilepsy Society annual meeting  

BRUSSELS, Dec. 4, 2015 /PRNewswire/ — UCB is pleased to announce that 19 scientific abstracts have been accepted for poster presentation at the upcoming 69th American Epilepsy Society (AES) annual meeting, which takes place from 4th to 8th of December in Philadelphia, PA, USA. The accepted poster presentations1-19 will cover a range of topics, including three1-3 relating to UCB’s approved anti-epileptic drug VIMPAT® (lacosamide) C-V, which is approved in the United States as monotherapy or adjunctive therapy for the treatment of partial-onset seizures in people with epilepsy aged 17 years and older.20 In the European Union, VIMPAT® is an approved adjunctive therapy for the treatment of partial-onset seizures with or without secondary generalization in adult and adolescent (16-18 years) patients with epilepsy.21  read more

Edison Issues ADR Research Update on SymBio Pharmaceuticals

LONDON, December 4, 2015 /PRNewswire/ —

SymBio recently acquired the exclusive rights to develop and market IONSYS, a fentanyl iontophoretic transdermal system for acute post-operative pain, in Japan. Treakisym is nearing a decision on additional indications and development is again moving ahead for rigosertib. With a third product in its development portfolio, we believe SymBio has the confidence to accelerate its in-licensing program on its quest to become the pharmaceutical partner of choice in Asia-Pacific.

SymBio Pharmaceuticals is a Japanese specialty pharma company with a focus on oncology, haematology and pain management. Treakisym was in-licensed from Astellas in 2005. Rigosertib was in-licensed from Onconova and IONSYS was in-licensed from The Medicines Company.

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