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Cangene to acquire U.S. commercialization rights for HepaGam B

Cangene Corporation today announces that it has signed an agreement with its majority shareholder, the Apotex Group, under which Cangene acquires all U.S. commercialization rights for HepaGam B(R) (Hepatitis B Immune Globulin Intravenous (Human)). HepaGam B(R) is Cangene's hepatitis B immune globulin, which is approved for treating two hepatitis-B-related indications in the U.S.

20 Oct 2009

Fluarix seasonal influenza vaccine approved by the FDA

The U.S. Food and Drug Administration today approved use of the seasonal influenza vaccine Fluarix for children ages 3 years to 17 years. Previously, this vaccine, which contains inactivated (killed) influenza A and B viruses, had been approved for use in adults, ages 18 years and older.

20 Oct 2009

GlaxoSmithKline may see increased sales of Relenza during the A/H1N1 2009 pandemic

Decision Resources, one of the world's leading research and advisory firms focusing on pharmaceutical and healthcare issues, finds that during the A/H1N1 (swine flu) pandemic, GlaxoSmithKline could see its Relenza sales increase if Tamiflu-resistant strains of the virus spread. GlaxoSmithKline recently signed A/H1N1 2009 vaccine contracts with various governments for more than $3 billion and is donating supplies to less wealthy nations, ensuring that the company strikes a balance between profit and public health concerns.

20 Oct 2009

AstraZeneca and POZEN announce the pivotal data from two POZEN clinical trials

AstraZeneca and POZEN Inc. today announced pivotal data from two POZEN clinical trials that were presented at the American College of Rheumatology (ACR) 2009 Annual Scientific Meeting in Philadelphia, PA.

20 Oct 2009

Menarini granted exclusive European licence rights to Ipsen's Adenuric

Ipsen, an innovation-driven global specialty pharmaceutical group, announced an agreement whereby Ipsen grants the Menarini Group the exclusive licence rights to Adenuric® (febuxostat) in 41 countries. Ipsen retains co-promotion rights for Adenuric® in France.

20 Oct 2009

Data on ULORIC treatment for gout flares presented at the 73rd American College of Rheumatology meeting

Data presented at the 73rd Annual Scientific Meeting of the American College of Rheumatology highlight effects of baseline characteristics on achievement of serum uric acid (sUA) levels to <6.0 mg/dL and the frequency of flares with ULORIC- (febuxostat) treatment.

20 Oct 2009

Hydra Biosciences and Cubist Pharmaceuticals join to develop novel ion channel drugs

Hydra Biosciences today announced that they have entered into an agreement with Cubist Pharmaceuticals, Inc. for a joint collaboration to develop novel ion channel drugs.

20 Oct 2009

Health Canada issues Notice of Non-Compliance to Winston Laboratories for CIVANEX

Winston Laboratories, Inc. (“Winston Labs”), a wholly-owned subsidiary of Winston Pharmaceuticals, Inc. today announced that it has received a Notice of Non-compliance (“NON”) from the Therapeutics Drug Directorate, Health Canada (the “Directorate”) for its New Drug Submission (NDS) for CIVANEX (zucapsaicin cream 0.075%) for the treatment of the signs and symptoms of osteoarthritis.

20 Oct 2009

Opinions: HIV vaccine; HIV resources help promote global disease control; U.S. fight against world hunger

Seth Berkley, president and chief executive of the International AIDS Vaccine Initiative, in a New York Times opinion piece examines how the "pessimism" over the recent controversy surrounding the results of an experimental HIV vaccine tested in Thailand "may ultimately thwart other efforts to develop an AIDS vaccine.

20 Oct 2009

Amylin Pharmaceuticals to present new data from its obesity program at Obesity 2009

Amylin Pharmaceuticals, Inc. today announced that new data from its obesity program will be presented at Obesity 2009, the 27th Annual Scientific Meeting of The Obesity Society, to be held in Washington, D.C. October 24-28. Phase 2 data from the pramlintide/metreleptin combination treatment clinical program will be the subject of a late-breaking oral presentation.

20 Oct 2009

Boehringer Ingelheim's TWYNSTA approved by FDA for the treatment of hypertension

Boehringer Ingelheim announced today that the US Food and Drug Administration (FDA) has approved TWYNSTA®, a new highly effective single pill combination therapy of telmisartan (an angiotensin receptor blocker [ARB]) and amlodipine (a calcium-channel blocker [CCB]). TWYNSTA® is indicated for the treatment of hypertension, alone or with other antihypertensive agents, and as initial therapy in patients who are likely to need multiple drugs to achieve their blood pressure goals.

20 Oct 2009

FDA approves new oral medication for renal cell carcinoma

The U.S. Food and Drug Administration today approved Votrient (pazopanib), the sixth drug to be approved for kidney cancer since 2005.

20 Oct 2009

WHO recommends antivirals for patients with symptoms of both H1N1, pneumonia

The WHO concluded a three-day meeting on H1N1 (swine flu) in Washington, D.C., on Friday, where health experts issued recommendations that patients with symptoms of H1N1 and pneumonia be treated quickly with antivirals, even before the results of H1N1 tests are complete, the San Francisco Chronicle blog, "ChronRX" reports (Allday, 10/16).

19 Oct 2009

URL Pharma's Colcrys approved by FDA for prevention of gout flares

URL Pharma, Inc., announced that the U.S. Food and Drug Administration (FDA) has approved Colcrys(TM) (colchicine, USP) for the prophylaxis (prevention) of gout flares. Colcrys was first approved by the FDA on July 30, 2009 for the treatment of acute gout flares when taken at the first sign of a flare.

19 Oct 2009

Study on the economic impact of antibiotic overuse and antibiotic-resistant infections

The Alliance for the Prudent Use of Antibiotics (APUA) and Cook County Hospital (currently John H. Stroger, Jr. Hospital of Cook County), today announced the release of an eye-opening study on the economic impact of antibiotic overuse and antibiotic-resistant infections (ARIs) sponsored by an unrestricted educational grant from bioMerieux and the Centers for Disease Control and Prevention (CDC).

19 Oct 2009

FDA approves Boehringer Ingelheim's MICARDIS for the reduction of risk of heart attack

Boehringer Ingelheim announced today that the US Food and Drug Administration (FDA) has approved a new indication for MICARDIS® (telmisartan) for the reduction of the risk of myocardial infarction (heart attack), stroke, or death from cardiovascular (CV) causes in patients 55 years of age or older at high risk of developing major CV events who are unable to take ACE inhibitors. MICARDIS® is the first treatment in its class to be approved for this indication.

19 Oct 2009

FDA approves GlaxoSmithKline Biologicals' Cervarix for prevention of cervical cancer

The FDA today approved Cervarix, a new vaccine to prevent cervical cancer and precancerous lesions caused by human papillomavirus (HPV) types 16 and 18. The vaccine is approved for use in girls and women ages 10 years through 25 years.

19 Oct 2009

Hatch-Waxman patent infringement litigation concerning Duac Gel dismissed

Perrigo Company announced today that the Hatch-Waxman litigation relating to Duac® Gel (clindamycin phosphate (1%) and benzoyl peroxide (5%) gel) filed by the Stiefel Laboratories division of Glaxo SmithKline has been dismissed with prejudice.

19 Oct 2009

Boehringer Ingelheim Pharmaceuticals receives NDA approval from FDA for its Micardis Tablets 80 mg

Boehringer Ingelheim Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) approved the supplemental New Drug Application (sNDA) for its angiotensin II receptor blocker (ARB) Micardis® (telmisartan) Tablets 80 mg for reduction of the risk of myocardial infarction, stroke, or death from cardiovascular causes in patients 55 years of age or older at high risk of developing major cardiovascular events who are unable to take angiotensin-converting enzyme (ACE) inhibitors.(1) MICARDIS is the most studied ARB in this high-risk patient population and has been commercially available to treat hypertension (high blood pressure) since its approval in 1998.

19 Oct 2009

Update from Endo Pharmaceuticals regarding its New Drug Application for FORTESTA

Endo Pharmaceuticals today announced that it received a Complete Response letter from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for FORTESTA(TM) (testosterone) 2% Gel for men diagnosed with low testosterone (Low T), also known as hypogonadism.

19 Oct 2009

Pharmaceutical News

Cangene to acquire U.S. commercialization rights for HepaGam B

Fluarix seasonal influenza vaccine approved by the FDA

GlaxoSmithKline may see increased sales of Relenza during the A/H1N1 2009 pandemic

AstraZeneca and POZEN announce the pivotal data from two POZEN clinical trials

Menarini granted exclusive European licence rights to Ipsen's Adenuric

Data on ULORIC treatment for gout flares presented at the 73rd American College of Rheumatology meeting

Hydra Biosciences and Cubist Pharmaceuticals join to develop novel ion channel drugs

Health Canada issues Notice of Non-Compliance to Winston Laboratories for CIVANEX

Opinions: HIV vaccine; HIV resources help promote global disease control; U.S. fight against world hunger

Amylin Pharmaceuticals to present new data from its obesity program at Obesity 2009

Boehringer Ingelheim's TWYNSTA approved by FDA for the treatment of hypertension

FDA approves new oral medication for renal cell carcinoma

WHO recommends antivirals for patients with symptoms of both H1N1, pneumonia

URL Pharma's Colcrys approved by FDA for prevention of gout flares

Study on the economic impact of antibiotic overuse and antibiotic-resistant infections

FDA approves Boehringer Ingelheim's MICARDIS for the reduction of risk of heart attack

FDA approves GlaxoSmithKline Biologicals' Cervarix for prevention of cervical cancer

Hatch-Waxman patent infringement litigation concerning Duac Gel dismissed

Boehringer Ingelheim Pharmaceuticals receives NDA approval from FDA for its Micardis Tablets 80 mg

Update from Endo Pharmaceuticals regarding its New Drug Application for FORTESTA

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