Sanofi and Regeneron Pharmaceuticals said on Tuesday that a study into their new cholesterol-lowering drug, Praluent, showed promising results. “In a new pooled analysis of heterozygous familial hypercholesterolaemia (HeFH) patients … Praluent significantly reduced bad cholesterol,” the French company said in a statement, referring to low-density lipoprotein cholesterol (LDL-C). “This analysis included 1,257 HeFH patients, […]
There were as many billion-dollar brands in 2017 as there have been in any other calendar year despite the cratering effects of massive patent cliffs in 2012 and 2015.
Current health systems built to evaluate and pay for traditional drugs are going to struggle with gene and other unusual therapies – but manufacturers can take steps before launch to define how manufacturers assess and value these new products.
This yearly review analyzes recent developments, trends and outlooks in the areas of biotechnology, biosimilars, biopharmaceuticals, biologics, biomarkers and biobanks.
A recent study of DTC advertising appearing in the Journal of General Internal Medicine concluded that few broadcast ads are compliant with FDA’s guidelines. The reality, though, might not be so cut and dried.
As more innovative – yet even more expensive – therapies enter the U.S. market, brand marketers will have to find equally new and innovative ways to prove the value of their medicines to payers and patients, especially as insurance plans continue to put more of the cost burden on patients.
On Oct. 28, 2016, my mother, Joan Biamonte, died of complications from metastatic carcinoma of the lung. Despite having her original tumor characterized and going through a regimen of chemotherapy allegedly tailored to her tumor type, her cancer proliferated and spread into her liver and brain.
Amgen is launching its injectable cholesterol drug in Europe at around half the U.S. price, in a move likely to stoke controversy about the way Americans end up paying far more than others for new medicines. Repatha belongs to a potent and expensive new class of drugs for lowering “bad” LDL cholesterol, whose high cost […]
Teva Announces U.S. Availability of ZECUITY® (sumatriptan iontophoretic transdermal system), First and Only Transdermal Patch System for the Acute Treatment of Migraine
JERUSALEM–(BUSINESS WIRE)–Sep. 1, 2015– Teva Pharmaceutical Industries Ltd.(NYSE:TEVA) today announced that ZECUITY®, the first and only patch system designed to provide relief from migraine, is now available by prescription through specialty pharmacies. ZECUITY® is a single-use, disposable patch system that delivers sumatriptan through the skin. The device is designed to be worn for a four-hour […]
San Francisco-based Audentes Therapeutics, announced today that it will buy Cardiogen Sciences, Inc., headquartered in Palo Alto, Calif. Financial details were not disclosed. Audentes focuses on developing and commercializing adeno-associated virus (AAV) gene therapies for rare diseases. It currently has three products in development, AT001 for X-Linked Myotubular Myopathy (XLMTM), AT002 for Pompe disease, […]
Global evidence from EXPLORER research program reports real-world bleeding rates in XARELTO® (rivaroxaban) patients with non-valvular atrial fibrillation LONDON, Sept. 1, 2015 /PRNewswire/ — Janssen Pharmaceuticals, Inc., and its development partner, Bayer HealthCare, today announced results from PMSS (Post-Marketing Safety Surveillance) and XANTUS (XARELTO® for Prevention of Stroke in Patients with Atrial Fibrillation), their […]
Drugmaker Bristol-Myers Squibb said it bought rights to a mid-stage fibrosis drug and its privately held developer for up to $1.25 billion, boosting its pipeline for drugs that treat tissue scarring. The deal gives Bristol-Myers access to Promedior Inc’s lead experimental drug, PRM-151, which is being tested to treat two types of fibrosis. PRM-151 is […]
Bayer will move a new heart failure drug into final-stage testing this year, boosting its ambitions in cardiovascular medicine, after the experimental medicine proved better than an older rival in a mid-stage trial. Having done well with recently launched drugs like stroke prevention pill Xarelto and eye treatment Eylea, the German group is eager to […]
A new drug in early development cuts cholesterol as much as two potent injections recently cleared for sale but lasts much longer, meaning it may need to be given only every three to six months, initial findings suggest. Results with Alnylam Pharmaceuticals and Medicines Co’s experimental product ALN-PCSsc highlight the competition for a market tipped […]
GOTEBORG, Sweden — Could Meda AB be selling off its U.S. operations? Some sources are suggesting a deal could be in the works. Late Thursday, Bloomberg Business, citing “people familiar with the matter,” reported Sweden-based Meda was exploring options to sell off its U.S. operations which have an estimated value of $1 billion. Meda, which […]
The U.S. Food and Drug Administration on Thursday approved Amgen Inc’s Repatha drug for patients with hereditary forms of high cholesterol and those with cardiovascular disease. Last month the FDA approved a similar drug from Regeneron Pharmaceuticals Inc and Sanofi SA. The drugs belong to a potent new class of injectable LDL-lowering drugs known as […]
Cheaper versions of biologic drugs would be identified by a suffix to distinguish them from their more expensive, branded counterparts under draft guidance issued on Thursday by the U.S. Food and Drug Administration. The FDA said its proposal is designed to prevent inadvertent substitution of non-interchangeable products and to make it easier to monitor and […]
LAS VEGAS, Aug. 27, 2015 /PRNewswire/ — The nation’s newest Actos trial gets underway Thursday, August 27th in a Las Vegas courtroom. Attorneys representing two southern Nevada patients will argue the men suffered severe effects, including death, after using the diabetes drug Actos. “Takeda Pharmaceuticals withheld from our clients what they as a company knew, […]
U.S. FDA approves Synjardy (empagliflozin/metformin hydrochloride) tablets for adults with type 2 diabetes
RIDGEFIELD, Conn. and INDIANAPOLIS, Aug. 27, 2015 /PRNewswire/ — The U.S. Food and Drug Administration (FDA) has approved Synjardy® (empagliflozin and metformin hydrochloride) tablets, from Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI) and Eli Lilly and Company (NYSE: LLY), for the treatment of adults with type 2 diabetes (T2D). SYNJARDY is the third product containing empagliflozin to […]
Sucampo Launches Tender Offer to Acquire R-Tech Ueno Acquisition Expected to be Immediately Accretive Advances Sucampo Strategy to Strengthen Financial Performance and Diversify Pipeline Acquisition Expected to Close in Q4 2015 Company to Host Conference Call Today at 8:00 a.m. EDT BETHESDA, Md., Aug. 26, 2015 (GLOBE NEWSWIRE) — Sucampo Pharmaceuticals, Inc. (NASDAQ:SCMP) today […]
Eli Lilly & Co. said a federal court ruled that generic products proposed by a Teva Pharmaceutical Industries Ltd. TEVA -0.43 % unit would infringe a U.S. patent for the drug maker’s blockbuster cancer drug Alimta. A Teva spokesman said “we are disappointed with the district court’s decision and we are evaluating our options to […]
Mylan Confirms the U.S. Patent and Trademark Office Institutes Inter Partes Review Proceedings against Two Copaxone® 40 mg/mL Dosing Patents
HERTFORDSHIRE, England and PITTSBURGH, Aug. 25, 2015 /PRNewswire/ — Mylan N.V. (Nasdaq: MYL) today announced that the U.S. Patent and Trademark Office (PTO) has instituted inter partes review (IPR) proceedings against two Copaxone® 40 mg/mL patents, U.S. Patent Nos. 8,232,250 and 8,399,413, owned by Yeda Research & Development Co., Ltd. and licensed to Teva Pharmaceuticals Industries […]
A U.S. patent review board on Monday declined to review petitions brought by hedge-fund manager Kyle Bass, who has sought to employ an unusual trading strategy of challenging patents held by pharmaceutical companies and profiting from declines in their stock prices. The U.S. Patent and Trademark Office’s review board ruled against Mr. Bass’s challenge of […]
EAST HANOVER, N.J., Aug. 24, 2015 /PRNewswire/ — Novartis announced today that the US Food and Drug Administration (FDA) has approved an expanded use for Promacta® (eltrombopag) to include children 1 year of age and older with chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy. The updated label […]
Prominent hedge fund manager Kyle Bass’s campaign to wipe out certain drug patents hit a roadblock on Monday when the U.S. Patent and Trademark Office declined to formally review two patents on Acorda Therapeutics Inc’s flagship multiple sclerosis drug, Ampyra. The decision to reject a review of the patents’ validity comes as the pharmaceutical industry […]
The big worries on growth hanging over the pharmaceuticals industry are poles apart. Pressure on U.S. drug pricing is casting a shadow over the sector’s most lucrative market. But slowing emerging-market growth, notably in China, shouldn’t be ignored. Emerging-market sales for the big pharmaceuticals firms tracked by Sanford C. Bernstein increased by about 5.5%, year […]