Content about drug development

March 26, 2014

Early-stage Alzheimer’s disease, or AD, increasingly is the target of drug development efforts, but there are very few tools that measure the cognitive function of patients with the condition before the onset of dementia. Experts have concluded that it is best to treat patients prior to changes in cognition, before the symptoms of neurodegeneration appear. As a result, scientists have turned to biomarkers to provide some indication of whether AD is likely to develop.

Early-stage Alzheimer’s disease, or AD, increasingly is the target of drug development efforts, but there are very few tools that measure the cognitive function of patients with the condition before the onset of dementia. Experts have concluded that it is best to treat patients prior to changes in cognition, before the symptoms of neurodegeneration appear. As a result, scientists have turned to biomarkers to provide some indication of whether AD is likely to develop.

February 18, 2014

Actavis and Forest Labs. announced that they have entered into a definitive agreement under which Actavis will acquire Forest for a combination of cash and equity valued at approximately $25 billion, or $89.48 per Forest share ($26.04 in cash and 0.3306 Actavis shares for each share of Forest common stock).

DUBLIN — Actavis and Forest Labs. on Tuesday announced that they have entered into a definitive agreement under which Actavis will acquire Forest for a combination of cash and equity valued at approximately $25 billion, or $89.48 per Forest share ($26.04 in cash and 0.3306 Actavis shares for each share of Forest common stock). The per share consideration represents a premium of approximately 25% per share over Forest’s stock price, and a premium of approximately 31% over Forest’s 10-day volume weighted average stock price, as of the close of trading on Feb.

February 4, 2014

The Pharmaceutical Research and Manufacturers of America on Tuesday announced a partnership with the National Institutes of Health that will help spur drug development, the association stated.

WASHINGTON — The Pharmaceutical Research and Manufacturers of America on Tuesday announced a partnership with the National Institutes of Health that will help spur drug development, the association stated. 

The Accelerating Medicines Partnership — an initiative of NIH, several non-profit disease foundations, 10 biopharmaceutical companies and PhRMA — aims to transform the current model for developing new diagnostics and treatments by joining forces to identify and validate promising biological targets of disease. 

July 18, 2013

Almost twice as many drugs for neglected diseases have received regulatory approval around the world over the past few years compared with the beginning of the last decade, according to a new study.

BOSTON — Almost twice as many drugs for neglected diseases have received regulatory approval around the world over the past few years compared with the beginning of the last decade, according to a new study.

July 9, 2013

Amgen will get rights to a drug for cardiovascular disease approved in the European Union under a new deal with French drug maker Servier, the two companies said.

THOUSAND OAKS, Calif. — Amgen will get rights to a drug for cardiovascular disease approved in the European Union under a new deal with French drug maker Servier, the two companies said Tuesday.

April 25, 2013

Galderma, whose brands include Cetaphil, and The American Academy of Dermatology have announced the creation of the American Academy of Dermatology Translational Biotechnology Fellowship.

CHAUMBURG, Ill., and SOPHIA ANTIPOLIS, France — Galderma, whose brands include Cetaphil, and The American Academy of Dermatology have announced the creation of the American Academy of Dermatology Translational Biotechnology Fellowship.

April 16, 2013

DSN spoke at length with two Catamaran executives — Albert Thigpen, SVP pharmacy operations and industry relations, and Sumit Dutta, SVP and chief medical officer — about the PBM’s new approach to managed pharmacy care and the changes driving that strategy.

The health and pharmacy marketplace is undergoing rapid and fundamental transformation. To navigate profitably in tomorrow’s complex and shifting healthcare system, the pharmacy benefit management industry — along with the pharmacies and health plan payers allied with PBMs — are going to have to change and adapt as well.

February 28, 2013

Has the explosion in generic utilization curbed pioneer-drug research and development? That's one concern floated by some pharmaceutical industry watchers, who claim that the stunning market share gains made by generic drug makers could reduce incentives for branded drug companies to spend to develop new molecular entities, conduct lengthy clinical trials, gain FDA approval and bring those new drugs to market.

Has the explosion in generic utilization curbed pioneer-drug research and development? That's one concern floated by some pharmaceutical industry watchers, who claim that the stunning market share gains made by generic drug makers could reduce incentives for branded drug companies to spend to develop new molecular entities, conduct lengthy clinical trials, gain FDA approval and bring those new drugs to market.

December 28, 2012

Solidifying Perrigo’s leadership position in topical foam-based generic prescription pharmaceuticals, the company announced it has signed a definitive merger agreement and completed the acquisition of Cobrek Pharmaceuticals.

ALLEGAN, Mich. — Solidifying Perrigo’s leadership position in topical foam-based generic prescription pharmaceuticals, the company announced it has signed a definitive merger agreement and completed the acquisition of Cobrek Pharmaceuticals, a privately-held, Chicago-based drug development company, for approximately $45 million.

November 16, 2012

Kroger announced Thursday it will acquire the outstanding shares of Axium Pharmacy Holdings, a leading specialty pharmacy, and merge the two companies. By now, it should be clear that specialty is becoming an increasingly important part of the retail pharmacy mix, having grown more than sixfold in revenues between 2000 and 2011, with everyone from Rite Aid to Costco to Hy-Vee biting off a piece for themselves.

As Specialty Pharmacy magazine reported in its fall 2012 issue, specialty drug development is starting to play a much bigger role in drug development overall than traditional pharmaceuticals. According to the IMS Institute for Healthcare Informatics, seven of the top 20 drug therapy classes will be in specialty by 2016, including cancer, autoimmune disorders and antivirals, and specialty and bioengineered drugs remain one of the few growth centers in the drug industry in 2012. And according to Express Scripts, the market for specialty and bioengineered drugs is expected to grow from 2011's 17.1% to 22% by 2014.

Kroger announced Thursday it will acquire the outstanding shares of Axium Pharmacy Holdings, a leading specialty pharmacy, and merge the two companies. By now, it should be clear that specialty is becoming an increasingly important part of the retail pharmacy mix, having grown more than sixfold in revenues between 2000 and 2011, with everyone from Rite Aid to Costco to Hy-Vee biting off a piece for themselves.

September 24, 2012

The Food and Drug Administration is creating a new task force to support the development of new drugs for bacterial infections, the agency said Monday.

SILVER SPRING, Md. — The Food and Drug Administration is creating a new task force to support the development of new drugs for bacterial infections, the agency said Monday.

The FDA said the Antibacterial Drug Development Task Force would assist in developing and revising guidance related to development of antibiotics, as required by the Generating Antibiotic Incentives Now Title of the FDA Safety and Innovation Act, which president Barack Obama signed into law on July 9.

September 20, 2012

French drug maker Sanofi announced a deal with the Global Alliance for TB Drug Development Thursday to develop drugs for tuberculosis.

NEW YORK — French drug maker Sanofi announced a deal with the Global Alliance for TB Drug Development to develop drugs for tuberculosis.

The drug maker and the TB Alliance said the deal will include discovery and development of new drug compounds for the disease, which caused almost 1.5 million deaths globally and affected nearly 9 million in 2010, according to the World Health Organization.

June 21, 2012

Taken together, asthma and chronic obstructive pulmonary disease — which includes chronic bronchitis and emphysema — affect nearly 50 million Americans, or about 15% of the total U.S. population, according to statistics from such organizations as the Centers for Disease Control and Prevention.

Taken together, asthma and chronic obstructive pulmonary disease — which includes chronic bronchitis and emphysema — affect nearly 50 million Americans, or about 15% of the total U.S. population, according to statistics from such organizations as the Centers for Disease Control and Prevention. And combined, the two diseases cause more than 100,000 deaths per year. Fortunately, however, there is a wide range of treatments available for both, many of which work for both diseases.


June 14, 2012

Novo Nordisk and the Juvenile Diabetes Research Foundation on Wednesday announced the creation of a joint research and development team to discover and develop novel immunotherapies to prevent, treat and help cure Type 1 diabetes.

NEW YORK — Novo Nordisk and the Juvenile Diabetes Research Foundation on Wednesday announced the creation of a joint research and development team to discover and develop novel immunotherapies to prevent, treat and help cure Type 1 diabetes.

May 23, 2012

Taken together, asthma and chronic obstructive pulmonary disease — which includes chronic bronchitis and emphysema — affect nearly 50 million Americans, or about 15% of the total U.S. population, according to statistics from such organizations as the Centers for Disease Control and Prevention. And combined, the two diseases cause more than 100,000 deaths per year. Fortunately, however, there is a wide range of treatments available for both, many of which work for both diseases.

Taken together, asthma and chronic obstructive pulmonary disease — which includes chronic bronchitis and emphysema — affect nearly 50 million Americans, or about 15% of the total U.S. population, according to statistics from such organizations as the Centers for Disease Control and Prevention. And combined, the two diseases cause more than 100,000 deaths per year. Fortunately, however, there is a wide range of treatments available for both, many of which work for both diseases.

May 4, 2012

A 30% rise in attendance at the Armada Specialty Pharmacy Summit is nothing to brush off — it's as clear an indication as any that specialty pharmacy is growing and probably poised for more growth in the near future, thanks in particular to the aging population and consequential rise in the number of people living with difficult-to-treat medical conditions.

WHAT IT MEANS AND WHY IT'S IMPORTANT — A 30% rise in attendance at the Armada Specialty Pharmacy Summit is nothing to brush off — it's as clear an indication as any that specialty pharmacy is growing and probably poised for more growth in the near future, thanks in particular to the aging population and consequential rise in the number of people living with difficult-to-treat medical conditions.

February 17, 2012

One of the main plotlines of the big story called the drug industry over the past several years has been the patent cliff, the steady loss of patent protection on blockbuster primary care drugs and subsequent generic competition that has forced many drug companies to find new revenue streams.

One of the main plotlines of the big story called the drug industry over the past several years has been the patent cliff, the steady loss of patent protection on blockbuster primary care drugs and subsequent generic competition that has forced many drug companies to find new revenue streams. Much of this has taken place in the form of a gradual shift to specialty drugs for such conditions as cancers and autoimmune disorders, but recent developments have shown that primary care drugs may still have some steam left in them.


February 3, 2012

For all the fears about the patent cliff, at least one disease state seems to be on the up-and-up in terms of new drug development and new products.

WHAT IT MEANS AND WHY IT'S IMPORTANT — For all the fears about the patent cliff, at least one disease state seems to be on the up-and-up in terms of new drug development and new products.

(THE NEWS: FDA approves Bydureon. For the full story, click here.)

December 23, 2011

Drug makers will focus on patient-specific therapies instead of drugs designed for use by a broad range of people over the next decade, according to a new report released Thursday by Thomson Reuters.

PHILADELPHIA — Drug makers will focus on patient-specific therapies instead of drugs designed for use by a broad range of people over the next decade, according to a new report released Thursday by Thomson Reuters.

The report, titled "The Changing Role of Chemistry in Drug Discovery" and based on drug industry productivity, patent data and other dynamics and trends, was released in recognition of the International Year of Chemistry 2011.

November 17, 2011

The increase in the number of people with rheumatoid arthritis, and the challenges posed to drug makers by generics, is encouraging the development of new drugs for the disease, according to a new report by Frost & Sullivan.

MOUNTAIN VIEW, Calif. — The increase in the number of people with rheumatoid arthritis, and the challenges posed to drug makers by generics, is encouraging the development of new drugs for the disease, according to a new report by Frost & Sullivan.

July 7, 2011

Merck KGaA division Merck Serono has appointed Belen Garijo as COO and Annalisa Jenkins as global head of drug development and medical, effective Sept. 5.

DARMSTADT, Germany — Merck KGaA division Merck Serono has appointed Belen Garijo as COO and Annalisa Jenkins as global head of drug development and medical, effective Sept. 5.

The company, which operates under the name "EMD" in the United States and is a separate company from U.S.-based Merck, said Garijo and Jenkins will be based in Geneva and will report to president Stefan Oschmann.

Garijo previously worked for Sanofi, where he was SVP global operations for the European region, while Jenkins was SVP global medical for Bristol-Myers Squibb.

June 30, 2011

Drug maker UCB and Harvard University have entered a research alliance that is designed to advance ongoing Harvard research projects along the drug development pathway.

BOSTON and BRUSSELS — Drug maker UCB and Harvard University have entered a research alliance that is designed to advance ongoing Harvard research projects along the drug development pathway.

UCB said it will bring its expertise in antibody generation and medicinal chemistry into the alliance and will provide up to $6 million over two years to fund specific innovative research projects led by Harvard scientists. The collaboration focuses on the central nervous system and immunology, UCB said.

June 23, 2011

One-third of spending on mental health in the United States, or $42 million, goes toward anxiety disorders, according to a new report by Companies & Markets.

LONDON — One-third of spending on mental health in the United States, or $42 million, goes toward anxiety disorders, according to a new report by Companies & Markets.

The report found that the global anxiety disorders market would likely rise in value to $5.9 billion by 2017, thanks to increasing stress levels exacerbated by an unstable economic climate, the aging of the population, an increase in patients with anxiety disorders and new drug development.

May 16, 2011

Amylin Pharmaceuticals filed suit against Eli Lilly in federal court Monday concerning an agreement between the latter and German drug maker Boehringer Ingelheim to develop drugs for diabetes.

SAN DIEGO — Amylin Pharmaceuticals filed suit against Eli Lilly in federal court Monday concerning an agreement between the latter and German drug maker Boehringer Ingelheim to develop drugs for diabetes.

In a complaint filed in the U.S. District Court for the Southern District of California, Amylin said Lilly engaged in unlawful and anticompetitive activity in its development and commercialization agreement with BI for Tradjenta (linagliptin), an orally administered Type 2 diabetes drug that the Food and Drug Administration recently approved.

January 13, 2011

Various companies in the healthcare industry are uncertain about the benefits of the Food and Drug Administration’s risk evaluation and mitigation strategy program, and most think it needs a major overhaul, according to a study by the Tufts University Center for the Study of Drug Development.

BOSTON — Various companies in the healthcare industry are uncertain about the benefits of the Food and Drug Administration’s risk evaluation and mitigation strategy program, and most think it needs a major overhaul, according to a study by the Tufts University Center for the Study of Drug Development.

The CSDD called the study the first systematic look at REMS since the FDA introduced the program in 2008. The FDA requires drug companies to create a REMS when the agency decides it is necessary to ensure that a drug’s benefits outweigh its risks.