Ernst & Young issued its yearly report on the biotechnology industry and one key takeaway is that young companies need to more quickly assess their value to patients and payers.
The report is entitled Beyond Borders: Matters of Evidence, and was released Tuesday.
E&Y's surveyed biotech leaders and found that 57 percent have already raised capital more aggressively from financial investors and 39 percent have had layoffs or downsized the facilities. But only 11 percent added payer reimbursement expertise to the management ranks.
It might shock many patients that this doesn't already exist, but four U.S. senators are pushing a bill that would eventually require every pill bottle be to traceable through each step of the pharmaceutical supply chain.
"Over the past few years, we’ve had a record number of recalls and reports of tainted or ineffective drugs reaching our hospitals and drug store shelves,” Colorado Sen. Michael Bennet (D) said in a statement. “In fact, right now, we know more from a barcode on a gallon of milk than from a barcode on a bottle of pills, which could mean the difference between life and death. This draft bill would put steps in place to prevent and reduce those problems and help ensure our drug supply is safe.”
A key phrase in Bennet's statement is "draft bill," meaning its chances of passing in current form is uncertain at best.
Pfizer, Merck, GlaxoSmithKline and Johnson & Johnson are among the pharmaceutical companies with Boston-area operations, so they had employees stay home or stay in the office if they were already at work Friday.
Massachusetts Gov. Deval Patrick Friday morning requested that people stay put as law enforcement personnel search for suspects in Monday's Boston Marathon bombing.
"All Pfizer sites in the Cambridge/Boston area remain closed until further notice," Pfizer said in a statement. "Our colleagues have been instructed to follow the directions of law local enforcement."
Months ago at an investor day, a Wall Street analyst in the audience during the question-and-answer portion of the event, told Merck & Co. CEO Ken Frazier that he liked what Merck was doing, but that he really, really, really wished Frazier would give some fresh, positive news on a drug - any drug - so the analyst could have a reason to tell clients to buy Merck stock.
The analyst was doing his job, but the conversation and the last few days point to one of many diametrically opposing forces in the pharmaceutical industry.
Even when put on what companies call a fast track, drugs take years to produce. And when a big pharmaceutical company strikes a deal with a start-up because the latter has a molecule in early phase trials, nobody can say for sure what profit will come of the arrangement years into the future.
A Food and Drug Administration panel was split Thursday on whether Malvern-based Endo Health Solutions' testosterone drug Aveed was safe enough to be approved.
The FDA is not required to follow votes by advisory committees, but a 9-9 split combined with a 17-1 negative vote on the company's suggested approach for delivering the injectable drug would be a disappointment for the company, which has tried several times to get the drug approved for use in a growing market.
Thursday's gathering was a joint meeting of the Advisory Committee for Reproductive Health Drugs and Drug Safety and Risk Management Advisory Committee Meeting Announcement. The official agenda statement was:
The Food and Drug Administration late Tuesday halted plans of generic drug companies hoping to sell their versions of the opioid painkiller OxyContin starting this week.
Under pressure to help thwart deaths from opioid painkiller overdose deaths, the FDA said it had approved new labeling for the reformulated OxyContin tablets, which are harder to crush, smoke or inject.
The new label for the brand-name drug means the FDA won't approve generic versions, which are supposed to essentially copy whatever is deemed the standard of care.
Though its Fort Washington plant is still being under repair and overall profits fell 10 percent in the first quarter of 2013, Johnson & Johnson said Tuesday that it has put more Tylenol and Motrin on store shelves in the United States through its McNeil Consumer Healthcare unit.
"We are pleased with results in our consumer division, with over-the-counter sales in the U.S. up 14 percent," J&J chief financial officer Dominic Caruso said in a conference call with stock market analysts.
J&J's consumer division includes products from outside the domain of the McNeil unit, which has both its headquarters and the idle factory in Fort Washington, Montgomery County. Johnson & Johnson is based in New Brunswick, N.J., and it has multiple divisions in the Philadelphia region. Besides the facilities in Fort Washington, the McNeil unit also has plants in Lancaster and Las Piedras, Puerto Rico.
The U.S. Supreme Court Monday denied a request by drugmaker GlaxoSmithKline to hear its appeal of a decision by U.S. Court of Appeals for the Third Circuit, which allowed health insurance giant Humana to sue Glaxo over sales of Glaxo's controversial diabetes drug Avandia.
The Third Circuit is based in Philadelphia and the original suit was filed there. Glaxo also has a huge presence in the city and surrounding suburbs.
Glaxo agreed to pay paid millions to settle lawsuits over the Avandia and has agreed to reimburse Medicare for the cost of treating Medicare patients. But a small slice of Medicare law allows private insurers who run Medicare Advantage programs to sue under similar reimbursement scenarios. Glaxo had sued to stop the lawsuits and hoped that conflicting opinions among courts of appeal might prompt Supreme Court review of the underlying law.
WASHINGTON - Molecules and chocolate chip cookies, baseball bats and Amazonian tree sap were all part of a spirited Supreme Court discussion Monday as the nine justices wrestled with the question of whether you should be able to get a patent for a human gene.
If you slice up pieces of microscopic molecules, have you created new ones or just separated existing body parts, not unlike kidneys or livers, which are products of nature and not usually granted patents? And, more importantly in this matter, can you profit by preventing others from researching those molecules or providing lower-cost testing services?
The justices seemed to be looking for a compromise in the case of Association for Molecular Pathology v. Myriad Genetics, Inc., 12-398. AMP was part of the original group of plaintiffs that represented researchers, including two from the University of Pennsylvania, patient groups and six women, including one from Williamsport, with breast or ovarian cancer or family history of it. The plaintiffs say Myriad's patent-provided monopoly on the BRCA1 and BRCA2 genes has stifled research because of Myriad's threats of lawsuits and less access to affordable testing for those cancers.
Myriad Genetics will tell Supreme Court its patents are worthy because their did more than slice and dice genes
Myriad Genetics will defend its gene patents Monday in the U.S. Supreme Court, and part of its public relations defense is that by isolating genes, it has created a synthetic piece of DNA worthy of the exclusivity that a patent brings.
A link to Sunday's Inquirer story is here.
The case is Association for Molecular Pathology v. Myriad Genetics, Inc., 12-398.