Amphastar Pharmaceuticals (NSDQ:AMPH) said this week that the FDA denied its subsidiary’s new drug application for the latest version of its Primatene Mist epinephrine inhaler. The complete response letter from the federal watchdog told Amphastar’s subsidiary, Armstrong Pharmaceuticals, that the company needs to change the inhaler’s label and packaging. The FDA also recommended that the company […]
Wall Street Beat
Provectus axes CEO Culpepper for expense account violations
Provectus Biopharmaceuticals Inc. (OTCQB:PVCT) said this week that its board of directors voted unanimously to terminate CEO and chief operating officer Peter Culpepper, after an internal investigation revealed that Culpepper violated the company’s expense account reimbursement policy. The Knoxville, Tenn.-based company said it has established a search committee and is actively seeking a new CEO. […]
IntelGenx, Endo Ventures ink development and commercialization deal
IntelGenx (OTCQX:IGXT) said today that it inked a development and commercialization deal with pharmaceutical company Endo Ventures. According to the agreement, the 2 companies will develop a new product using IntelGenx’s VersaFilm drug delivery technology to bring to the market in the U.S. Endo will have certain exclusive rights to market and sell the product in the […]
Sanofi sues Nordisk over Tresiba marketing claims in U.S.
Sanofi (NYSE:SNY) said yesterday that it is suing competitor Novo Nordisk (NYSE:NVO) for “misleading” marketing materials that claim Sanofi’s insulin drugs Lantus and Toujeo will be “blocked” by U.S. pharmacy benefit manager CVS Caremark in January and that patients should switch to Nordisk’s Tresiba. CVS is replacing both Sanofi’s and Nordisk’s drugs with Eli Lilly’s Basaglar on […]
Mesoblast gains on A$29m investment deal with Mallinckrodt
Shares in stem cell company Mesoblast Ltd (ASX:MSB) rose 7% to A$1.51 yesterday after it said that it entered into an equity purchase agreement with US drugmaker Mallinckrodt Pharmaceuticals (NYSE:MNK). Mallinckrodt will buy 20.04 million, or nearly 5%, of Mesoblast’s ordinary shares for A$1.48 apiece. According to the agreement, Mallinckrodt will have 9 months to […]
Teva coughs up $519m to settle overseas bribery charges
Teva Pharmaceuticals (NYSE:TEVA) will pay $519 million to settle allegations that the company bribed overseas officials in Mexico, Russia and Ukraine to promote its products, according to the U.S. Justice Dept. The department reported that the millions of dollars in bribes occurred for more than a decade. The pharmaceutical giant agreed to $238 million to […]
Sunovion, Novartis ink licensing deal for inhaled COPD drugs
Novartis (NYSE:NVS) said today that it out-licensed its U.S. commercial rights for 3 chronic obstructive pulmonary disease drugs to Sunovion Pharmaceuticals. Novartis will commercialize the Utibron Neohaler, Seebri Neohaler, and Arcapta Neohaler inhalation powders outside of the U.S. The Switzerland-based company will manufacture the inhaled powders for Sunovion, according to the agreement. “Given the evolving market […]
Another warning for CareFusion’s Alaris drug pump
The U.K.’s Medicines & Healthcare Products Regulatory Agency issued a warning today for Carefusion‘s Alaris syringe drug pumps. The UK watchdog said that Alaris pumps with broken springs in the plunger assembly could accidentally release a single dose of medication if the pump also uses non-recommended syringes. “This problem comes about through a combination of using […]
Actelion, J&J re-enter takeover negotations
Actelion (VTX:ATLN) and Johnson & Johnson (NYSE:JNJ) have re-entered talks to reach a takeover deal, after the US healthcare giant reportedly abandoned its efforts last week. Some suggest that this could mean the end of Sanofi‘s (NYSE:SNY) attempt to make a deal with the Swiss biotech firm, according to Reuters. J&J and Actelion had been engaged in informal talks […]
Fluor to build Novo Nordisk’s $2b manufacturing facility in North Carolina
Fluor Corporation (NYSE:FLR) said yesterday that it landed a contract to build Novo Nordisk‘s (NYSE:NVO) $2 billion diabetes active pharmaceutical ingredient manufacturing facility in Clayton, North Carolina. Since Denmark-based Novo Nordisk announced plans for the facility in August 2015, Fluor has been providing basic design services for the project. The manufacturing facility will measure 830,000 […]
