Pharmaceutical company Mallinckrodt PLC said its profit soared in the latest quarter as the company’s specialty brand sales continue to benefit from recent acquisitions. But overall sales missed analysts’ lofty expectations, and shares slid 10.4% in midday trading—hitting a six-month low and giving up nearly half of the stock’s gain this year. In March, the […]
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).
Regeneron Inc’s blockbuster eye drug, Eylea, showed no signs of a slowdown as the drugmaker raised the full-year sales forecast for its flagship product above at least four analysts’ expectation. The company’s shares rose to a record of $605.93 in early trading on Tuesday. U.S. sales of Eylea surged 58 percent to $655 million in […]
Akorn Inc’s Hi-Tech Pharmacal Co, Inc infringed three Allergan Inc patents on its Lumigan topical glaucoma treatment, a U.S. appeals court ruled on Tuesday. The U.S. Court of Appeals for the Federal Circuit also said five of Allergan’s Lumigan patents were valid. The case stems from lawsuits Allergan filed in 2011 against Hi-Tech, Novartis AG, […]
Drug industry productivity is continuing to improve, with a bumper haul of new products being launched and companies proving more successful in the final stages of clinical testing, according to a new analysis. Data from Thomson Reuters published on Tuesday showed the number of innovative medicines, or new molecular entities, launched globally in 2014 hit […]
PHILADELPHIA, Aug. 4, 2015 /PRNewswire/ — The Intellectual Property and Science business of Thomson Reuters, the world’s leading provider of intelligent information for businesses and professionals announced the release of the 2015 CMR Pharmaceutical R&D Factbook, the biopharmaceutical industry’s leading resource of global R&D trends. Despite concerns around declines in R&D, the analysis identifies a surge […]
Eli Lilly & Co on Tuesday will confront the first U.S. trial over allegations it failed to warn users of its popular antidepressant Cymbalta that they could suffer severe withdrawal symptoms, including suicidal thoughts and electric shock-like sensations. Plaintiff Claudia Herrera is one of about 250 people who have sued Lilly over Cymbalta, and the […]
The U.S. Food and Drug Administration has, for the first time, approved a drug that uses 3D printing technology, paving the way for potential customization of drugs to suit patients’ needs. The drug, made by privately held Aprecia Pharmaceuticals Co, was approved for oral use as a prescription adjunctive therapy in the treatment of epilepsy, […]
BLUE ASH, Ohio, Aug. 3, 2015 /PRNewswire/ — Aprecia Pharmaceuticals Company today announced that the U.S. Food and Drug Administration (FDA) has approved SPRITAM® levetiracetam for oral use as a prescription adjunctive therapy in the treatment of partial onset seizures, myoclonic seizures and primary generalized tonic-clonic seizures in adults and children with epilepsy. SPRITAM utilizes Aprecia’s […]
New cancer drug cocktails set to reach the market in the next few years will test the limits of premium pricing for life-saving medicines, forcing company executives to consider fresh market strategies. The growing reluctance of governments and private insurers to fund very expensive drugs – even remarkably effective ones – points to a showdown […]
A difficult feat to accomplish in business is to make dramatic change in the midst of current success. History is littered with companies that were once on top of the world and today are non-existent or merely footnotes because they were unable to make sustainable changes when times were good and yet change was required. […]
At the very end of its 2015 half-year financial report, on page 49, AstraZeneca PLC (AZN) noted the termination of three projects between April 1 and June 30. They were a program for selumetinib for uveal melanoma, tenapanor for ESRD-pi/CKD with T2DM and Nexium for refractory reflux esophagitis. The selumetinib and tenapanor programs were halted […]
FDA Approves Bayer’s Finacea (azelaic acid) Foam, 15% for the Topical Treatment of the Inflammatory Papules and Pustules of Mild to Moderate Rosacea
WHIPPANY, N.J., July 31, 2015 /PRNewswire/ — Bayer HealthCare today announced that the U.S. Food and Drug Administration (FDA) has approved Finacea® (azelaic acid) Foam, 15% for the topical treatment of the inflammatory papules and pustules of mild to moderate rosacea. The approval is based on results from two pivotal clinical trials examining the efficacy and […]
OSAKA, Japan, July 30, 2015 /PRNewswire/ — Guidance for FY2015 confirmed, including Core Earnings and Core EPS Highlights of Q1 results • Underlying revenue +6.1% year-to-year (reported revenue growing +8.5% to 446.3 billion yen)•Underlying core earnings and underlying core EPS were flat, year-to-yearGrowth supported by innovative new products •The growth of new products was sufficient […]
July 31, 2015By Alex Keown, BioSpace.com Breaking News Staff CAMBRIDGE, Mass. – A Bloomberg survey of 30 investors indicates Biogen (BIIB) needs to enter the M&A fray sooner than expected in order to boost revenue, the business site reported this morning. Asthika Goonewardene, a health-care analyst for Bloomberg Intelligence, said the Boston-based drugmaker should acquire […]
Amgen Inc. raised its 2015 guidance after reporting that its second-quarter earnings rose 6.9% on better-than-expected sales growth and lower operating expenses. For the year, the biotechnology company now expects per-share earnings of $9.55 to $9.80 and revenue of $21.1 billion to $21.4 billion, compared with its previously boosted estimate for per-share profit of $9.35 […]
Takeda Announces Completion of the Pioglitazone Post-Marketing Commitment and Submission of Results to the EMA, the FDA and the PMDA
OSAKA, Japan, July 30, 2015 /PRNewswire/ — Takeda Pharmaceutical Company Limited (“Takeda”) today announced the completion of the study to fulfill the post-marketing commitment and submissions of data to regulatory authorities from the Pan European Multi-Database Bladder Cancer Risk Characterization Study, a large (n= 112,674), multi-database retrospective matched cohort study, conducted in four European countries, for […]
Teva Pharmaceutical Industries (TEVA.N), which this week revealed plans to buy Allergan’s (AGN.N) generics drugs business in a $40.5 billion deal, said on Thursday sales of its branded multiple sclerosis drug Copaxone rose 12 percent in the second quarter even though it faces new competition. Teva, the world’s biggest generic drug maker, said that global […]
* Q2 Business net income up 4.2 percent, above expectations * Analyst says Toujeo sales “underwhelming” * CEO Brandicourt to unveil strategic plan on Nov.6, open to M&A * Shares down 0.45 percent (Adds details, shares, comments) By Matthias Blamont and Noëlle Mennella PARIS, July 30 (Reuters) – Sanofi reported lower second quarter sales for […]
By Denise Roland The Wall Street Journal Biography @deniseroland email@example.com Updated July 30, 2015 7:51 a.m. ET AstraZeneca PLC on Thursday reported an increase in second-quarter revenue, thanks to proceeds from licensing deals, though profits continued to fall as the company plowed heavy investment into new drugs it hopes will replace its old blockbusters. The […]
July 30, 2015By Mark Terry, BioSpace.com Breaking News Staff Paris-based Sanofi (SNY) announced solid growth for the second quarter today. The company’s group sales rose by 4.9 percent for the quarter to €9.378 billion. While sales were a little weak for Diabetes, dropping 3.8 percent, Genzyme (SNY) more than made up for it with 26.6 […]