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NCCTG to conduct Phase II study of brostallicin in combination with cisplatin for mTNBC cancer

Cell Therapeutics, Inc. today announced that the North Central Cancer Treatment Group ("NCCTG") plans to conduct a Phase II study of brostallicin in combination with cisplatin in patients with metastatic triple-negative breast ("mTNBC") cancer, defined by tumors lacking expression of estrogen, progesterone receptors and without over-expression of HER2. Additionally, the majority of breast cancers that are associated with the susceptibility mutation (BRCA1) are of the triple-negative type.

28 Apr 2010

Shire receives Paragraph IV Notice Letter from Anchen over filing of ANDA for generic INTUNIV

Shire plc, the global specialty biopharmaceutical company, announces that it has received a Paragraph IV Notice Letter from Anchen Pharmaceuticals, Inc. advising of the filing of an Abbreviated New Drug Application for a generic version of Shire's 1 mg, 2 mg, 3 mg, and 4 mg guanfacine hydrochloride extended release tablets, INTUNIV(TM).

28 Apr 2010

Takeda announces submission of azilsartan medoxomil NDA for hypertension to FDA

Takeda Pharmaceutical Company Limited (Takeda) announced today that Takeda Global Research & Development Center, Inc., U.S., submitted a New Drug Application (NDA) to the United States Food and Drug Administration (FDA) for azilsartan medoxomil (development code: TAK-491), an angiotensin II receptor blocker (ARB) under investigation for the treatment of hypertension. Discovered by Takeda, azilsartan medoxomil is designed to lower blood pressure by blocking the action of a vasopressor hormone, angiotensin II.

28 Apr 2010

Hana Biosciences announces completion of Marqibo pre-NDA meeting with FDA

Hana Biosciences, a biopharmaceutical company focused on strengthening the foundation of cancer care, today announced that the Company has completed a pre-New Drug Application (NDA) meeting with the U.S. Food and Drug Administration (FDA) related to its lead product candidate, Marqibo for the treatment of relapsed/refractory adult Philadelphia chromosome-negative acute lymphoblastic leukemia (ALL).

28 Apr 2010

Protalix BioTherapeutics submits validation data for taliglucerase alfa manufacturing process to the FDA

Protalix BioTherapeutics, Inc., announced today it has submitted validation data regarding the Company's manufacturing process for taliglucerase alfa to the U.S. Food and Drug Administration (FDA). The Company made the submission in response to a request from the FDA for validation data from the Company's upgraded manufacturing facility. The FDA is currently reviewing the Company's New Drug Application (NDA) for taliglucerase alfa for the treatment of Gaucher disease.

27 Apr 2010

PPD confirms Japanese approval for Takeda's NESINA NDA

PPD, Inc. today confirmed that Takeda Pharmaceutical Company Limited's new drug application for NESINA® (alogliptin), a highly selective DPP-4 inhibitor for the treatment of type 2 diabetes, was approved by the Japanese Ministry of Health, Labour and Welfare on April 16. PPD's compound partnering division collaborated with Takeda to develop this product.

27 Apr 2010

Watson Laboratories sued by Teva Women's Health over generic Cenestin ANDA

Watson Pharmaceuticals, Inc. today confirmed that its subsidiary, Watson Laboratories, Inc., a Nevada Corporation, has been sued by Teva Women's Health, Inc., in connection with the filing of Watson's Abbreviated New Drug Application (ANDA) for synthetic conjugated estrogens, A, in the 0.3 mg, 0.45 mg, 0.625 mg, 0.9 mg and 1.25 mg tablet strengths. Watson's ANDA is for the generic equivalent of Teva's Cenestin®. The suit was filed on April 23, 2010, in the United States District Court for the District of New Jersey.

27 Apr 2010

Stinging FDA review for Acurox – the implications

The US FDA’s advisory panel’s decision to recommend against approval of Acura Pharmaceuticals/King Pharmaceuticals’ Acurox (oxycodone plus niacin) was based upon the view that data were lacking that niacin-induced flushing could potentially reduce misuse of Acurox with single-ingredient oxycodone. The panel also contended that clinical studies were not conducted in populations that might be likely to benefit from the drug’s purported abuse-deterrent properties, such as those with chronic pain and adolescents who are experimenting with drug use.

27 Apr 2010

Covidien introduces PENNSAID to the U.S. market

Covidien, a leading global provider of healthcare products, has introduced PENNSAID (diclofenac sodium topical solution) 1.5% w/w to the U.S. market. PENNSAID is the only FDA-approved topical non-steroidal anti-inflammatory drug in a vehicle solution containing dimethyl sulfoxide, a known penetrating agent. It is indicated for treatment of the signs and symptoms of osteoarthritis of the knee(s).

26 Apr 2010

Nycomed, Merck enter co-promotion agreement for Daxas in Canada and Europe

Nycomed and Merck & Co., Inc. (based in Whitehouse Station, New Jersey and known as MSD outside the USA and Canada) today announced that they have entered into a co-promotion agreement for Canada and certain European countries for the commercialization of Daxas® (roflumilast), an investigational once-daily tablet for patients with chronic obstructive pulmonary disease (COPD). In addition, the two companies have signed an exclusive distribution agreement for the commercialization of Daxas® in the United Kingdom.

26 Apr 2010

Animal studies demonstrate safety profile of ACT's RPE cell therapy for SMD

Advanced Cell Technology, Inc. announced today that it has completed key animal studies in connection with its Phase I multicenter study using embryonic stem cell derived Retinal Pigment Epithelium (RPE) cells to treat patients with Stargardt's Macular Dystrophy (SMD), for which it filed an Investigational New Drug Application (IND) with the US Food and Drug Administration (FDA) in November. The studies demonstrated an excellent safety profile with no safety signals such as tumors or ectopic tissues.

24 Apr 2010

Victoza produces greater reductions in A1C, FPG and body weight than Januvia: Study

Yesterday, The Lancet published online the results of the first study comparing the once-daily human GLP-1 analog, Victoza (liraglutide [rDNA] injection) with a DPP-4 inhibitor, Januvia. The 26-week trial showed that Victoza produced significantly greater reductions in A1C, fasting plasma glucose, and body weight than Januvia, with similar or better overall treatment satisfaction.

24 Apr 2010

FDA rejects experimental painkiller Acurox

In a new development King Pharmaceuticals Inc. and Acura Pharmaceuticals Inc. have failed to win the approval of a US panel for marketing an experimental painkiller called Acurox.

23 Apr 2010

FDA Advisory Committees vote against approval of Acurox NDA

Acura Pharmaceuticals, Inc. and King Pharmaceuticals®, Inc. today announced that the U.S. Food and Drug Administration's (FDA) Anesthetic and Life Support Drugs and Drug Safety and Risk Management Committees voted that they do not have enough evidence to support the approval of the New Drug Application (NDA) for Acurox® (oxycodone HCl and niacin) Tablets for the treatment of moderate to severe pain, considering the deterrent effects of niacin as well as the potential deterrent effects of the other features specific to Acurox®.

23 Apr 2010

Amylin, Eli Lilly and Alkermes reply to FDA complete response letter for BYDUREON NDA

Amylin Pharmaceuticals, Inc., Eli Lilly and Company and Alkermes, Inc. today announced that the companies have submitted their reply to a complete response letter issued last month by the U.S. Food and Drug Administration (FDA) after review of the New Drug Application (NDA) submission for BYDUREON™ (exenatide for extended-release injectable suspension).

23 Apr 2010

Alexion Pharmaceuticals reports total revenues of $117.6M from net product sales of Soliris

Alexion Pharmaceuticals, Inc. today announced financial results for the quarter ended March 31, 2010.

22 Apr 2010

Delcath Systems' trial meets primary endpoint of extended hPFS in patients with melanoma metastases

Delcath Systems, Inc., a development stage, oncology-focused, specialty pharmaceutical and medical device company, announced that its Phase III National Cancer Institute (NCI)-led multi-center clinical trial has successfully met the study's primary endpoint of extended hepatic progression-free survival (hPFS) in patients with melanoma metastases to the liver based on an independently corroborated intent-to-treat analysis.

22 Apr 2010

FDA approves Akorn's ANDA supplement for Erythromycin

Akorn, Inc. a niche generic pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has granted approval of the Company's Abbreviated New Drug Application (ANDA) supplement for Erythromycin Ophthalmic Ointment USP 3.5 g. The company intends to begin shipping the product immediately.

22 Apr 2010

Catabasis Pharmaceuticals to advance program targeting type 2 diabetes with $39.6 million Series A financing

Catabasis Pharmaceuticals, a biopharmaceutical company developing novel therapeutics for the treatment of inflammatory and metabolic diseases, today announced it has completed a $39.6 million Series A financing led by SV Life Sciences, Clarus Ventures, and MedImmune Ventures. Also participating in the round is Advanced Technology Ventures.

21 Apr 2010

ZIOP Chief Medical Officer receives grant to develop novel treatment for pediatric sarcoma

The Kristen Ann Carr Fund has awarded a grant to Jonathan Lewis, MD, PhD, Chief Executive Officer and Chief Medical Officer of ZIOPHARM Oncology, Inc., which will fund translational work at the Memorial Sloan-Kettering Cancer Center and the Albert Einstein College of Medicine in New York City, for the development of a novel treatment for pediatric sarcoma.

21 Apr 2010

New Drug Application News and Research

NCCTG to conduct Phase II study of brostallicin in combination with cisplatin for mTNBC cancer

Shire receives Paragraph IV Notice Letter from Anchen over filing of ANDA for generic INTUNIV

Takeda announces submission of azilsartan medoxomil NDA for hypertension to FDA

Hana Biosciences announces completion of Marqibo pre-NDA meeting with FDA

Protalix BioTherapeutics submits validation data for taliglucerase alfa manufacturing process to the FDA

PPD confirms Japanese approval for Takeda's NESINA NDA

Watson Laboratories sued by Teva Women's Health over generic Cenestin ANDA

Stinging FDA review for Acurox – the implications

Covidien introduces PENNSAID to the U.S. market

Nycomed, Merck enter co-promotion agreement for Daxas in Canada and Europe

Animal studies demonstrate safety profile of ACT's RPE cell therapy for SMD

Victoza produces greater reductions in A1C, FPG and body weight than Januvia: Study

FDA rejects experimental painkiller Acurox

FDA Advisory Committees vote against approval of Acurox NDA

Amylin, Eli Lilly and Alkermes reply to FDA complete response letter for BYDUREON NDA

Alexion Pharmaceuticals reports total revenues of $117.6M from net product sales of Soliris

Delcath Systems' trial meets primary endpoint of extended hPFS in patients with melanoma metastases

FDA approves Akorn's ANDA supplement for Erythromycin

Catabasis Pharmaceuticals to advance program targeting type 2 diabetes with $39.6 million Series A financing

ZIOP Chief Medical Officer receives grant to develop novel treatment for pediatric sarcoma

Advancing Intracellular Delivery with LumiPore®

How ELRIG Is Helping Mid-Career Scientists Navigate Leadership, Career Change and Redundancy

The role of UV-Vis in biopharma QC

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