Optimer Pharmaceuticals, Inc. (NASDAQ: OPTR) announced today that the U.S. Food and Drug Administration (FDA) has approved the company’s antibacterial drug DIFICID™ (fidaxomicin) tablets for the treatment of Clostridium difficile-associated diarrhea (CDAD) in adults 18 years of age and older. CDAD is a significant medical problem in hospitals and long-term care facilities, and is beginning to emerge in the community among people previously at low risk for the disease. In the largest Phase 3 clinical studies ever conducted in CDAD, DIFICID had clinical response rates at the end of treatment that were non-inferior to oral vancomycin. DIFICID was superior to vancomycin in sustaining clinical response through 25 days beyond the end of treatment. DIFICID is the only FDA-approved antibacterial drug proven to be superior to vancomycin in sustained clinical response for CDAD.
To view Multimedia News Release, go to http://multivu.prnewswire.com/mnr/optimerpharma/50177/
Raptor Pharmaceutical Corp. (“Raptor” or the “Company”) (Nasdaq: RPTP), today announced that the U.S. Food and Drug Administration (FDA) has approved PROCYSBI™ (cysteamine bitartrate) delayed release capsules for the treatment of nephropathic cystinosis in adults and children 6 years and older. In a Phase 3 study, PROCYSBI showed consistent cystine depletion over the full 12-hour dosing period. Sustained levels of cysteamine have not historically been achieved in the majority of patients in this population. Studies have shown that sustained cystine depletion in patients may significantly delay disease progression, including kidney dysfunction, dialysis, kidney transplant, organ failure and premature death.
To view Multimedia News Release, go to http://www.multivu.com/mnr/61338-raptor-pharmaceutical-procysbi-fda-approval-nephropathic-cystinosis
CPhI Worldwide, part of UBM Live’s Pharmaceutical Portfolio, today celebrates its 25th birthday by releasing the first in a series of ‘made at CPhI’ pharma stories. These will follow 25 pharma industry successes that have directly resulted from meetings at CPhI. The first story charts Global Pharmaceutical Relief from a first meeting at CPhI only two years ago to today and providing hundreds of millions of dollars worth of medicines to the developing world via NGOs- not just another business story, but a great example of the CPhI family helping to proliferate healthcare throughout the globe.
To view the Multimedia News Release, go to http://www.multivu.com/players/English/72762554-cphi-worldwide-celebrates-25-years/
Nationally-recognized and long-standing sports announcer Jerry Punch, M.D., is teaming up with Men’s Health Network and Endo Pharmaceuticals Inc., a subsidiary of Endo International plc (NASDAQ: ENDP) (TSX: ENL), to launch “Ask About the Curve,” a new educational campaign designed to raise awareness of Peyronie’s disease. Peyronie’s disease is a little-known men’s health condition that can occur during midlife or later. And, while the disease is physical in nature, the impact may also be psychological and could possibly hold men back from talking about it.
Peyronie’s disease, or “PD,” is a condition that can cause curvature of the penis that could be painful during arousal and intimacy. It can affect as many as one in 10 men worldwide, but diagnosis rates remain low because men with PD may be too uncomfortable to speak up and get help. Together with Endo and Men’s Health Network, Dr. Punch is encouraging men who think they might have PD to face their challenge head on by starting the conversation with their doctor.
“As a sports commentator, I’ve witnessed thousands of men on the court, on the field and on the racetrack in their physical prime – cool, confident and thriving in the face of challenge. But, as a licensed physician, I’ve seen how this bravado can turn to embarrassment – even isolation – when that challenge becomes personal or intimate,” said Dr. Punch. “Often, men feel too awkward to talk about issues like Peyronie’s disease, even with a doctor. And while it may seem tough, it’s important that any man with PD see a doctor, and ask about the curve. Starting the conversation is the first step to getting help.”
To view the multimedia release go to:
http://www.multivu.com/players/English/7752151-ask-about-the-curve-psa/
Almirall, S.A. (ALM:MC) and Ironwood Pharmaceuticals, Inc. (NASDAQ:IRWD) announced today that the European Commission has granted marketing authorization to Constella® (linaclotide 290mcg) for the symptomatic treatment of moderate to severe Irritable Bowel Syndrome with Constipation (IBS-C) in adults . This approval follows the positive recommendation received from the European Committee for Medicinal Products for Human Use (CHMP) in September.
To view Multimedia News Release, go to http://www.multivu.com/mnr/58658-almirall
After an unexpected diagnosis of atrial fibrillation (AFib), a type of irregular heart beat they had never heard of before, daytime TV star Susan Lucci and her husband Helmut Huber learned he is one of the estimated 2.3 million Americans living with the condition, which can increase the risk of stroke nearly five-fold. The couple, who have spent more than a decade working with their doctor to help minimize Helmut’s stroke risk, today announced they have partnered with Boehringer Ingelheim Pharmaceuticals, Inc., National Stroke Association and StopAfib.org to launch a new national education program to improve awareness of AFib and its increased risk of stroke.
To view Multimedia News Release, go to http://multivu.prnewswire.com/mnr/boehringer-ingelheim/46196/
GW Pharmaceuticals plc (Nasdaq: GWPH, “GW,” “the Company” or “the Group”), a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform, along with its U.S. subsidiary Greenwich Biosciences, announced today that The New England Journal of Medicine has published results from a Phase 3 study of Epidiolex® (cannabidiol) in children with Dravet syndrome.1 Epidiolex, GW’s lead product candidate and the potential first in a new category of anti-epileptic drugs, is a liquid formulation of purified, plant-derived cannabidiol (CBD), a non-psychoactive cannabinoid, which is being studied for the treatment of a number of rare, severe pediatric-onset epilepsy disorders. In the study, Epidiolex significantly reduced monthly convulsive seizure frequency compared to placebo in highly treatment-resistant children when added to existing treatment. Treatment with Epidiolex was generally well tolerated, with a safety profile consistent with prior open label experience.
To view the multimedia release go to:
https://www.multivu.com/players/uk/8109951-gw-pharmaceuticals-study-epidiolex/
ACG – the leading partner for pharmaceutical industry’s myriad requirements – is strengthening its product portfolio by launching several new machines at CPhI/P-MEC India, to be held during 2-4 December 2014, at Bombay Exhibition Centre, Mumbai.
P-MEC India, co-located with CPhI India, is one of the ‘must-attend’ events in the international pharmaceutical industry. With a booth that spreads over 1,000 sq. m., ACG will be displaying several new machines including the all-new ACG X.One Technology that reinvents the 12-bar safety features; Protab, a tablet press suited for small to medium batch sizes, and many more.
To view the Multimedia News Release, go to http://www.multivu.com/players/English/7391551-ACG-Launch-New-Machines-at-CPhI/
AbbVie (NYSE:ABBV) today marks its launch as an independent biopharmaceutical company, with employees from more than 40 countries and patients joining AbbVie leaders as they ring the first opening bell of 2013 at the New York Stock Exchange.
With a rich, 125-year heritage of developing pharmaceuticals, AbbVie combines the focus and passion of a leading-edge biotech with the expertise and structure of a long-established pharmaceutical leader. A global enterprise that serves patients in more than 170 countries, AbbVie launches with an estimated $18 billion in annual revenues and a strong commitment to creating shareholder value through long-term growth potential and the continuation of the company’s history of shareholder dividends.
To view Multimedia News Release, go to http://www.multivu.com/mnr/59757-abbvie-celebrates-launch-as-new-biopharmaceutical-company
