News

FDA in search of a new head for its Indian operations

When India-born Altaf Lal was named to run the FDA office in India last year, he pledged to work with Indian drugmakers there to improve quality and their chances of avoiding regulatory actions by the agency. But someone else will have to take on that challenge because Lal has left after just about 9 months on the job.

Aptuit putting $1M into cytotoxic capabilities in Scotland

Contract services company Aptuit will invest $1 million in its facility in Glasgow, Scotland, to expand its capacity to manufacture sterile cytotoxic liquid and lyophilized drug products.

Children's blood infections lead Teva to halt production of IV solution

Teva Pharmaceutical Industries, which in April had to recall a children's growth hormone, has now halted production of a parenteral nutrition product as the authorities try to determine why 9 children in Israel developed blood infections after taking it.

GSK recalls acetaminophen products that were not child-proofed

GlaxoSmithKline is voluntarily recalling four lots of its Panadol Advance product in 100-count bottles in Puerto Rico because the bottles do not have child-resistant packaging to protect against overdoses.

Baxter issues global recall of saline in midst of U.S. shortage

Baxter International has initiated a worldwide recall of three lots of sodium chloride as well as one of highly concentrated potassium chloride, the company announced today. The recall of the saline comes even as hospitals for months have been facing a shortage of the essential product.

J&J improves McNeil unit sales even as key plant remains closed for remediation

Johnson & Johnson has managed a turnaround in its McNeil Consumer Health division by producing products like Tylenol and Motrin at facilities other than its still-closed Fort Washington, PA, plant and getting them back on retailer's shelves.

Pfizer and Sun snatch up sterile injectable companies to boost expertise and capacity

The sterile injectables business holds promise for drugmakers with the manufacturing capabilities to produce the difficult-to-make drugs. Deals announced Wednesday by Pfizer and Sun Pharma were proof positive of how companies think they can cash in on the generics piece of this sterile injectables market.

FDA cites Italian API maker for deleting all analytics

FDA inspections have uncovered a number of Indian companies that have manipulated data on their active pharmaceutical ingredients and deleted test results that didn't conform to specifications, an issue that has led to warning letters and contributed to import alerts. Many of those makers have been in India, but a warning letter posted today for an Italian company shows the problem is universal.

Purdue moves forward with $59M plant in North Carolina

Purdue Pharma will build a new $59 million plant in Durham, NC, and has awarded a contract to KBR Building Group to erect the 188,000-square-foot facility.

Forest, Hospira, West-Ward and Baxter recall products; Mylan gets two plants in deal with Abbott;

> The FDA discusses the steps it has taken to protect the the international supply chain. Blog > The U.K.'s Medicines and Healthcare Products Regulatory Agency (MHRA), has told medical...

Glenmark to build $100M plant in North America

Glenmark has more than a dozen manufacturing plants around the world, recently opening a mAb manufacturing facility in Switzerland to feed its pipeline of monoclonal antibodies and biosimilars. But the Indian generics maker does not have a plant in North America and figures it is time.

Job-cutting Pfizer saves 100 jobs in Ireland

Pfizer has a reputation for being a company that will cut jobs deeply once a merger is done, a rap that raised a lot of fears during its run at AstraZeneca. But the U.S. drugmaker can now point to about 100 jobs in Ireland that it is sparing as business has improved.

GSK investing $25M for Codexis manufacturing technology

GlaxoSmithKline, an early adopter of continuous processing as a way to cut drug manufacturing costs and manufacturing waste, and thus its impact on the environment, is committing $25 million to license a technology from a California company that will allow the U.K. company to make a large leap forward in biocatalysis.

PhRMA, BIO, GPhA ask court to trash California drug disposal law

Pharmaceutical companies, which have been fighting a county drug disposal law in the California Bay area for nearly two years, say they exist to develop and produce drugs, not to be waste disposal companies. But that is what the law in Alameda County would require them to become, they told a federal appeals court.

Global CMOs tipped to enter Russia as local drug production deadline nears

While geopolitical instability in Eastern Europe would appear to make Russia a risky bet, the size of the market and incoming targets on drug production mean the likes of Abbott Laboratories are still investing. For companies unwilling or unable to strike deals like Abbott's $495 million buyout of Veropharm, a new option is tipped to emerge: CMOs.

Portfolio trimming by generics manufacturers linked to soaring drug costs

Dwindling pools of manufacturers for some generic drugs are driving up prices, The New York Times reports.

Report: Dendreon's costly manufacturing casts doubt on cancer vaccine viability

When Dendreon was trying to bring its cancer vaccine Provenge to market, many doubted whether it could overcome the associated manufacturing and logistical hurdles. Ultimately Dendreon did better than some expected, but not as well as it hoped. And the same problems that made the cost of producing and shipping Provenge a burden for Dendreon still hang over the sector.

India faces higher QC costs as Shasun shows value of compliance

Rising recognition of FDA scrutiny and the cost of quality failings have prompted Indian drugmakers to double spending on compliance over the past 5 years, credit rating agency Crisil reports. And Indian investors are increasingly conscious of the value of such investments, with Shasun Pharma seeing its stock jump 16% this week after it got through an FDA inspection with just a Form 483.

Serum Institute allies with biotech in bid to cut cost of biosimilar production

The biosimilars market has attracted some big companies with even bigger claims about their ability to drive down manufacturing costs, with Samsung and its ambition to undercut biologic prices by 50% the standout example. Now a small Australian biotech is trumpeting the cost-saving it can realize after marrying its expression technology to the scale of the Serum Institute of India.

U.K. commits cash to $24.7M industry-focused formulation center

Another piece of the United Kingdom's push to create a National Formulation Centre fell into place this week when a state-funded group joined with industry to commit £14.4 million ($24.7 million) to a product and process design facility. The new site will support companies with the development, prototyping and scale-up of formulated products.