U.K.-based GlaxoSmithKline (GSK) announced on April 14, 2015 that it was recalling all remaining lots of its 2014-2015 Flulaval Quadrivalent flu vaccine. The company noted that two of the components of the vaccine, the B strains, appeared to have lost potency below the minimum specifications. The potency issue, according to the company, the U.S. Centers […]
For the pharmaceutical industry, 2016 brought new blockbusters onto the market to ease the pain of patent expirations.
AbbVie’s biologic therapy Humira for autoimmune disorders continues to dominate the sales landscape; Gilead’s once-daily hepatitis C treatment Harvoni in 2016 repeated its performance as the world’s second-best-selling prescription medicine.
Just like 2016 and the year before, specialty drugs dominate the 2017 list of top performers in the most recent first year after launch class.
First Year After Launch: New molecular entities launched in the U.S. during 2015 that generated 2016 sales of at least $200 million
A listing of the the new molecular entities launched in the United States during 2015 that generated 2016 sales of at least $200 million
Lurking behind all the sound and fury in the political realm, 2017 is bringing new opportunities to marketers that have nothing at all to do with orange hair. A whole generation of technologies are growing to maturity together – predictive targeting, virtual reality, behavioral science, interactive video, big data, and more – all of which are transforming the ways in which brands can communicate with their audiences. But of course politics will matter too in this Year One of the Trump administration, as the continuing debate over drug pricing and the impact of the new president’s policies on the pharma industry remain very much up in the ai
There was a significant drop-off in NME approvals by FDA in 2016, but there were not enough new drug applications with user fee goals to reach the lofty 2015 total.
“Failing to plan is planning to fail” states time management guru Alan Lakein. Nowhere does this axiom ring more true than in the tightly controlled world of Rx launches. Given the time and expense required to bring a prescription drug to market, coupled with its limited exclusive lifespan, we must maximize every moment from market conditioning to loss of exclusivity (LOE).
UPPSALA, Sweden, April 20, 2015 /PRNewswire/ — Paclical, a novel formulation of paclitaxel based on Oasmia’s XR-17 technology, was approved for treatment of (i.e., it received market authorization for) epithelial ovarian cancer in combination with carboplatin. XR-17 is non-toxic and forms water soluble nanoparticles with paclitaxel. (Logo: http://photos.prnewswire.com/prnh/20150420/740096 ) The Russia-based company Pharmasyntez holds the […]
MUMBAI and MONTREAL, April 20, 2015 /PRNewswire/ — Zaxine 550mg (rifaximin) is a long term antibiotic treatment for adults living with hepatic encephalopathy (HE), a complication of liver disease (cirrhosis). HE can lead to a wide spectrum of mental and physical symptoms, including confusion, disruption in sleep patterns, personality changes and coma Zaxine® 550mg has approved by […]
(Reuters) – Teva Pharmaceutical Industries Ltd has agreed to pay $512 million to settle a class action claiming that Cephalon Inc, which Teva bought in 2011, used anticompetitive settlements to delay generic versions of its wakefulness drug Provigil, according to court papers. The settlement is the largest ever to be paid to drug buyers that […]
Merck’s immune-boosting cancer drug, Keytruda, bested the standard of care in advanced melanoma, the deadly skin cancer, and showed promising results in non-small cell lung cancer. Based on these data, Merck says it has filed an application with the Food and Drug Administration for Keytruda to be used in non-small cell lung cancer, and will soon […]
(Reuters Health) – Opiate prescriptions and overdoses in the U.S. have declined since the debut of an abuse-resistant version of the painkiller OxyContin and the market withdrawal of the narcotic Darvon, a study finds. Researchers reviewed insurance claims records with data on prescriptions and hospitalizations for more than 30 million adults covered by UnitedHealthCare from […]
Merck Announces Submission of Supplemental Biologics License Application to U.S. FDA for KEYTRUDA in Advanced Non-Small Cell Lung Cancer
KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the company has submitted a supplemental Biologics License Application to the U.S. Food and Drug Administration (FDA) for KEYTRUDA® (pembrolizumab), the company’s anti-PD-1 therapy, for the treatment of advanced non-small cell lung cancer (NSCLC). KEYTRUDA previously received Breakthrough Therapy […]
(Reuters) – Teva Pharmaceutical Industries shares slid five percent on Sunday after U.S. regulators approved a generic version of its top-selling multiple sclerosis drug and amid reports it was mulling a bid for rival Mylan. Teva’s Tel Aviv shares fell to 249.80 shekels ($64) late on Sunday, the first day of trading since both news […]
A large study of Bristol-Myers Squibb Co’s Opdivo treatment has been halted after proving the drug is effective against the most common form of lung cancer, the company said, positioning the medicine for far wider use than its already approved lung cancer and melanoma indications. The U.S. drugmaker on Friday said the study, called Checkmate-057, […]
Pfizer Inc. scored a key victory Friday when it was cleared of liability in the first U.S. trial involving claims that its antidepressant Zoloft can cause birth defects in children born to women who take the drug while pregnant. Plaintiff Kristyn Pesante claimed that Pfizer failed to warn that using Zoloft during pregnancy could […]
An Amgen sign is seen at the company’s office in South San Francisco, California, October 21, 2013. Reuters/Robert Galbraith (Reuters) – U.S. health regulators on Wednesday approved Amgen Inc’s Corlanor to treat patients with chronic heart failure, giving the world’s largest biotechnology company its first cardiovascular product. The Food and Drug Administration approved the use […]
As the waistline of Americans has increased, so has the incidence of Type 2 diabetes. Startling data from the Centers for Disease Control shows that that prevalence of this disease, which is directly related to obesity, now exceeds 9% in the adult population. It was less than half that rate in 1996. Furthermore, there doesn’t […]
Two diabetes drugs survived a meeting of the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee on Tuesday. Rejecting recommendations from critics that the drugs should either be withdrawn or get new restrictions on use, the committee voted against any harsh measures, recommending only that information from two neutral clinical trials with the drugs be added to the drugs’ labels. […]
A sign is seen at an AstraZeneca site in Macclesfield, central England May 19, 2014. Reuters/Phil Noble (Reuters) – AstraZeneca Plc’s diabetes drug Onglyza and Takeda Pharmaceutical Co.’s rival product Nesina should carry information about the risk of heart failure, an advisory committee to the U.S. Food and Drug Administration said on Tuesday. Heart […]
Soligenix Completes Phase 1 Clinical Study with SGX203 for the Treatment of Pediatric Crohn’s Disease
Princeton, NJ – June 28, 2013 – Soligenix, Inc. (OTCQB: SNGX) (Soligenix or the Company), a clinical stage biopharmaceutical company focused on developing products to treat inflammatory diseases and biodefense countermeasures where there remains an unmet medical need, announced today that it has enrolled and treated all patients in the Phase 1 Study BDP-PCD-01; the […]
FDA Grants Genentech’s Obinutuzumab (GA101) Priority Review for Previously Untreated Chronic Lymphocytic Leukemia (CLL) Announcement Follows FDA Breakthrough Therapy Designation for GA101 in CLL FDA Decision on the GA101 Biologics License Application (BLA) Is Expected by the End of 2013. South San Francisco, Calif. — July 2, 2013 — Genentech, a member of the Roche […]
HIV Positive Men Show No Signs of HIV after Bone Marrow Transplant and Discontinuation of Anti-Retroviral Therapy Boston, MA – Two Brigham and Women’s Hospital patients with longstanding HIV infections who underwent bone marrow transplants have stopped anti-retroviral therapy and have no detectable HIV in their blood cells. One patient stopped anti-retroviral therapy 15 weeks […]
Novartis Exelon® Patch now FDA approved to treat patients across all stages of Alzheimer’s disease Latest FDA approval based on high dose Exelon Patch 13.3 mg/24h for severe Alzheimer’s; 24-week study showed statistically significant improvement in overall cognition and function compared to 4.6 mg/24h dose Exelon Patch first and only transdermal therapy approved to treat […]
Click to download the PDF to view the full issue CNS Neurology Awaiting Approval (Excel Document) New Alzheimer’s disease treatments for presymptomatic patients will increase the Ad market size in the years ahead; the multiple sclerosis segment is undergoing a strong growth phase based on the arrival of promising molecules with disease-modifying characteristics and novel […]