All News

In the Food and Drug Administration?s draft revision of the 1987 Process Validation Guidance, the lack of clarity about how the revised guideline applies to legacy products and the potential burden of new requirements for ongoing process monitoring are common concerns raised in many of the comments submitted by industry to the agency. To date, more than 45 companies or organizations have submitted comments on the draft revision, issued in November 2008.

In addition to providing tax breaks and investing billions to jump start the economy, last month?s economic stimulus package supports healthcare for the unemployed and takes steps to modernize the nation?s troubled healthcare system.

Oxford Expression Technologies (OET, Oxford, UK) and Eden Biodesign (Liverpool, UK) have signed a co-marketing agreement.

Apotex, Inc. (Toronto, Canada) and Intas Biopharmaceuticals Limited (IBPL, Ahmendabad, India) have extended their business agreement to develop a biosimilar version of pegfilgrastim, a protein that is used to treat neutropenia (a side effect of cancer chemotherapy).

Even the best biotech companies lack a crystal ball. In 2003, Genentech had a shortage of manufacturing capacity. So they started an internal campaign, called "Every Gram Counts," to produce as much as possible.

The US Food and Drug Administration issued its first approval on February 6 for a biological product produced by genetically engineered animals.

Richter-Helm BioLogics GmbH & Co. KG (Hamburg, Germany) and Athera Biotechnologies AB (Stockholm, Sweden) have signed an agreement for the development and manufacturing of Annexin A5, Athera?s novel product for prevention of plaque rupture and athero-thrombosis.

With counterfeit and adulterated medicines posing an increasing risk to patients in the United States and worldwide, the US Pharmacopeial (USP, Rockville, MD) Convention announced on February 4, new standards for two widely used drug products that have been involved in episodes of adulteration resulting in patient deaths.

Following a discussion with the US Food and Drug Administration, ImClone Systems, acquired last fall by Eli Lilly and Company (New York, NY), and Bristol-Myers Squibb (New York, NY) have withdrawn the supplemental Biologics License Application for the use of Erubitux (cetuximab) in advanced non-small cell lung cancer.

The US Food and Drug Administration has launched a voluntary pilot program that will help promote the safety of drugs and active drug ingredients produced outside the United States.

Teva (Jerusalem, Israel), the world?s largest generics company, and Lonza (Basel, Switzerland) have formed a joint venture to develop, manufacture, and market biosimilars.

Indian biotechnology company Intas Biopharmaceuticals (IBPL, Ahmedabad, Gujarat) has signed a memorandum of understanding (MoU) with the government of Gujarat for setting up a separate manufacturing facility for Monoclonal Antibodies (MAbs).

AmVac AG (Zug, Switzerland) has formed a collaboration with the National Health Research Institutes in Taiwan to develop a nasal spray vaccine against the H5N1 avian influenza.

The US Food and Drug Administration has approved Gleevec (imatinib mesylate) for a new indication?keeping cancer from growing in patients following surgical removal of a gastrointestinal stromal tumor (GIST).

Novozymes (Bagsvaerd, Denmark) has entered into a global licensing and collaboration agreement with Sanofi-Aventis (Paris, France) for the development and marketing of a new potential antibiotic.

Intercell AG (Vienna, Austria) has begun the Phase 2 clinical trial of the company's vaccine candidate to prevent infections with the bacterium Pseudomonas aeruginosa.

Celvapan, the first cell culture-based H5N1 (avian flu) pandemic vaccine, has moved closer to approval in the European Union. On December 18, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA), issued a positive opinion, recommending market authorization for the vaccine, made by Baxter International, Inc. (Deerfield, IL).

AFFiRiS (Vienna, Austria) has initiated pre-clinical development of a Parkinson's vaccine. The vaccine, known as PD01, can be used to target a specific protein that is closely associated with the causes of this degenerative neurological disease.

PPD, Inc. (Wilmington, NC) has entered into a strategic collaboration with Merck & Co., Inc. (Whitehouse Station, NJ), involving vaccine testing and assay development.

On January 20, FDA Commissioner Andrew von Eschenback, MD, will step down as commissioner and Frank Torti, MD, will take over as acting commissioner.

MannKind Corporation (Valencia, CA) has purchased an option to license plant-produced recombinant human insulin from SemBioSys Genetics Inc. (Calgary, Canada) for use primarily in MannKind's ultra-rapid acting insulin, Afresa.

The US Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) opened HHS/FDA offices in Costa Rica on January 7. The HHS/FDA presence in the region will allow the countries to work closely together. The office in Costa Rica is the first in a series in Latin America, which will eventually include an HHS/FDA presence in South America and Mexico later in 2009.

The US Food and Drug Administration has issued a new draft guidance document on process validation. This much-awaited revision of the 1987 guidance of the same name has been in the works for at least three years, and is being welcomed by industry experts.

Although no official announcement has been made, former Senate majority leader Tom Daschle is most likely slated to head the Obama administration’s efforts to enact health reform legislation as the new secretary of the Department of Health and Human Services.

AstraZeneca has announced the divestment of the AstraZeneca Biotech Laboratory (ABL) in Södertälje, Sweden, to Recipharm AB of Sweden, a contract development and manufacturing organization.

Merck Serono (Darmstadt, Germany) has begun expansion of the Merck Serono Biotech Center (MSBC), its production site in Corsier-sur-Vevey, Switzerland.

In the Obama administration, an important ally in the House for Tom Daschle, who is expected to be named secretary of the Department of Health and Human Services, will be Rep. Henry Waxman (D-CA), who unseated John Dingell (D-MI), the long-time top Democrat on the House Energy and Commerce Committee, to become the panel’s new chairman.

The FDA has released its guidance on acceptable terms for cooperative manufacturing arrangements for short supply, divided manufacturing, and shared and contract manufacturing for licensed biologics.

GeoVax Labs, Inc. (Atlanta, GA) will launch its Phase 2a human vaccine trials in 12 sites across North and South America.

WuXi PharmaTech Inc. (Shanghai, China) will discontinue its US biologics manufacturing operations as of December 31, 2008.