News

Novartis puts New York plant that makes Diovan next on its shutdown list

Novartis is in the middle of tightening its focus and cutting down on costs. But as the Swiss drugmaker goes through the evaluation process, its North American manufacturing is taking some hits. The most recent is a New York plant that employs 525, which the company now confirms it will be shutting down.

Par bolsters its sterile manufacturing with a $490M deal to grab JHP

Par Pharmaceuticals will pay $490 million to pick up JHP Pharmaceuticals, paying two-and-a-half times what Warburg Pincus laid out for the sterile injectable drug producer last year.

J&J consumer health boosts results, even without a key plant

Johnson & Johnson has been working for nearly four years to overcome manufacturing problems at its key over-the-counter products plant in the U.S. and get the facility reopened. In a new sign that it is getting those problems behind it, even before the plant reopens, the drugmaker says the OTC unit posted a nearly 20% jump in U.S. sales last year as it got products like Tylenol and Motrin back in the hands of consumers.

Novartis manufacturing gets more jobs in major restructuring

Novartis is whacking support jobs in its pharmaceutical division but said it is adding elsewhere, including in over-the-counter manufacturing and supply chain, so that the company's headcount will remain unchanged at about 15,000, Reuters reports.

Saline shortage: FDA works with Baxter, Hospira and Braun

The FDA is warning healthcare providers that there is a shortage of saline solution, as well as other IV solutions. The agency says it is working with Baxter International--which recently had to recall four lots of saline--Hospira and Braun to boost production.

FDA recall questions the sterility of eye drops made in Vietnam

The FDA said Friday that Mentholatum is recalling a variety of over-the-counter eye drops after a review of manufacturing facilities raised questions of sterility. In another sign of the globalization issues facing the FDA, the drops being recalled were manufactured in Vietnam.

Aurobindo deal with Actavis accelerates its expansion of sterile injectables biz

Aurobindo has been looking to expand further in Europe, particularly in the sterile injectables business. With a €30 million ($41 million) deal to buy 7 Actavis active pharmaceutical ingredient facilities across Western Europe, the Indian company will be able to do that in one fell swoop.

Shire has a partially built plant for sale after unloading Dermagraft

Shire announced Friday it was selling the diabetic foot ulcer treatment to Canton, MA-based Organogenesis, which is not paying anything up front but could pay Shire up to $300 million if it meets sales targets up to 2018. With the deal, Organogenesis, which has its own foot ulcer product, gets the company's current 115,000-square-foot manufacturing plant in La Jolla, CA, but not the new facility.

UPDATED: Genentech resolves plant backup quickly but timing was bad

Roche last week said it had resolved packaging issues that resulted in the interruption of supplies of its liquid Tamiflu flu fighter. But while the interruption lasted less than two weeks, it couldn't have come at a worse time: at the beginning of the first quarter and right in the middle of the flu season. Last year, Tamiflu sales provided the Swiss drugmaker with a nice boost to first-quarter sales.

Actavis selling China assets as it exits that country

Actavis CEO Paul Bisaro says the company has sold a China unit and is in talks to unload another, telling Bloomberg he has decided to retreat from a country that isn't worth all of the effort it requires.

Sources: Ranbaxy asks the FDA to let it make generic Diovan in U.S.

Among all of the fallout from the well-publicized manufacturing mess at Ranbaxy Laboratories has been its inability to get a generic of Novartis' blockbuster hypertension fighter Diovan to market. Reports have now surfaced that indicate the Indian drugmaker wants to make the drug in the U.S., using an API supplied by another company.

FDA assigns an agent to Europol in its fight against fakes

The FDA's Office of Criminal Investigations is establishing a closer relationship with the Europol law enforcement agency to attack the problem of counterfeit drugs sold online at its source.

Premier supports the FDA's new compounder oversight plan

The FDA has an ally in its effort to get hospitals to buy compounded drugs from only those companies that volunteer to be regulated under a new FDA program. It is one with substantial reach. While healthcare improvement company Premier is not generally one to look favorably on federal regulation that affects its 2,900 member hospitals, it is urging its clients to get on board with this one.

Former Fresenius employee says he was fired for raising red flags

Former Fresenius employee Ronald Hillier has filed a state whistleblower lawsuit in Cook County in Chicago, alleging that when he pointed out issues that he believed could result in contaminated products, the company canned him. 

Merck recalls all lots of Liptruzet shipped since its May debut

Merck is recalling all of the lots of its cholesterol drug Lipruzet distributed since its approval in the U.S. last May, saying that packaging problems could affect its potency. It has warned the FDA that shortages are expected from the voluntary recall.

McKesson recalibrates its EU strategy after Celesio deal nosedives

McKesson, the largest U.S. wholesale distributor of drugs, decided it needed an EU strategy after competitor AmerisourceBergen made its own deal there last year. So it made an $8.3 billion bid for German wholesaler Celesio. But with its failure Monday to close the Celesio deal, the San Francisco-based company finds itself again figuring out how to establish a beachhead on the continent.

Wockhardt hires a new compliance exec in the face of FDA bans

India's Wockhardt, facing a raft of regulatory issues from the U.S. and Europe, is beefing up its quality oversight with a new leader for its regulatory and compliance division.

Ranbaxy manufacturing drama continues with FDA action on API plant

The Ohm Laboratories plant in New Jersey is currently Ranbaxy's only facility able to turn out product for the U.S. market. Now the FDA has raised questions about manufacturing practices at the active pharmaceutical plant that supplies about 70% of the raw ingredients for U.S. production, Ranbaxy's facility in Toansa.

China corruption probe takes a turn into domestic drug distribution business

A probe by Chinese authorities into alleged corruption in its pharma industry initially focused on drug manufacturers, and Western companies at that. But with the announcement that the former vice president of China's largest drug distributor has been detained, it has moved down the supply chain and firmly into its domestic industry. It also involves a company in a piece of the industry that is key to foreign drugmakers and one that has been tricky for them to navigate.

Aurobindo is looking to buy API plants from Actavis

Sources tell The Economic Times that Aurobindo is talking with Actavis about buying active pharmaceutical ingredient plants in Western Europe that it could integrate into its sterile injectables operation. They said Actavis is looking to sell facilities in Italy, Spain, France, Germany and the Netherlands, and the Indian drugmaker is looking to scoop up a couple of them.