A new piece of legislation proposed in the US House of Representatives would provide pharmaceutical manufacturers with incentives to develop tamper-resistant products by changing the rules of the competitive landscape. The Stop Tampering of Prescription Pills Act of 2012 , introduced by Rep. Bill Keating (D-MA) on 19 July, would first amend the Federal Food, Drug and Cosmetic Act (FD&C Act) to include a definition for "tamper-resistant drug[s]." Such a product ...

Life science manufacturing giant Johnson & Johnson has reportedly reached a tentative settlement agreement with a group of shareholders who had sued the company over allegations of chronically mismanaging its operations, leading to large-scale manufacturing problems and regulatory difficulties. The Associated Press reports the agreement came after J&J agreed to "big changes, including a new committee of independent board members to get reports about legal and q...

Life sciences manufacturer Johnson & Johnson's subsidiary Ethicon this week warned physicians about counterfeit copies of its Ligaclip Extra Ligating Clip Cartridges, which are used for tubal ligation. The company explained in a "Dear Healthcare Provider Letter" that its investigators had discovered counterfeit copies of the device in at least two countries-the US and Hong Kong-and the company was working with regulatory authorities in both countries to track the sou...

Life science manufacturing giant Johnson & Johnson (J&J) is in the final stages of agreeing with federal prosecutors to pay an estimated $2.2 billion to settle charges of improperly marketing its blockbuster antipsychotic drug Risperdal, reports Bloomberg . The $2.2 billion sum would, in addition to settling Risperdal claims, also settle litigation regarding the marketing of J&J's schizophrenia drug Invega and congestive heart failure drug Natrecor, report...

Johnson & Johnson subsidiary Ethicon announced on 5 June 2012 it will cease sales of a controversial line of vaginal mesh implant products after being hit with a series of lawsuits alleging the products cause internal bleeding. Bloomberg Businessweek reports the company has requested approval from the US Food and Drug Administration (FDA) to end sales of the product within the next 120 days so consumers and doctors can find alternate suppliers or other treatment op...

The US Food and Drug Administration's (FDA) Cardiovascular and Renal Drugs Advisory Committee voted against Johnson & Johnson and Bayer's co-developed oral anticoagulant drug Xarelto (rivaroxaban), which the companies were looking to market as a therapy for Acute Coronary Syndrome (ACS). Xarelto is already FDA-approved for reducing the risk of blood clots in limited populations. The advisory committee had expressed some doubts regarding the drug on 22 May, saying m...

An advisory committee to the US Food and Drug Administration (FDA) gave US-based manufacturer Johnson & Johnson's (J&J) blood thinner Xarelto (rixaroxaban), experimentally used to treat acute coronary syndrome (ACS), mixed reviews after taking issue with the quality of data used to support the drug. CNBC reports the panel of advisors was particularly troubled by missing data , including 12% of patients in the study and several deaths which were not counted in ...

Explosive allegations have emerged from two prominent Senators regarding marketing tactics used by a number of pharmaceutical companies, including Purdue Pharma, Endo Pharmaceuticals and Johnson & Johnson, which are alleged to have engaged in "misinformation and dubious marketing practices." The Senators, Max Baucus (D-MT) and Charles Grassley (R-IA), charge the companies were involved in establishing "improper relationships between [the companies] and the organizati...

A bipartisan bill introduced in the House of Representatives would work to speed up the development and review of some drugs intended to treat life-threatening diseases by creating a new "breakthrough therapy" designation at the US Food and Drug Administration (FDA). The bill, To amend chapter V of the Federal Food, Drug, and Cosmetic Act (FD&C Act) to expedite the development and review of breakthrough therapies , would amend the FD&C Act  to include pr...

After being backed by a US Food and Drug Administration (FDA) advisory committee , life sciences manufacturer Johnson & Johnson (J&J) has won FDA approval for Levaquin (levofloxacin), an antibiotic intended to treat pneumonic plague. The drug's approval is notable because it utilizes a rarely-used approval pathway known as the 'Animal Rule' pathway. The pathway allows sponsors of products intended to treat very dangerous or contagious conditions to forgo clinica...

Two life sciences giants are experiencing transitions in leadership, as AstraZeneca's Chief Executive Office David Brennan announced he was relinquishing his position effective immediately and incoming Johnson & Johnson (J&J) CEO Alex Gorsky assumes his position at the company on 26 April. Rumors of Brennan's departure have been brewing for some time, but finally came to a head after the firm announced a 19% decrease in first-quarter profits, reports Reuters . T...

Following in the footsteps of other successful partnerships between pharmaceutical manufacturers and patient groups, French life sciences company Sanofi is teaming up with the Michael J. Fox Foundation (MJFF) to collaborate on testing a new treatment for Parkinson's disease. The partnership will test a compound known as AVE 8112, a phosphodiesterase type 4 inhibitor, in a phase 1 b clinical trial to assess the drug's safety and tolerability, Sanofi said in a statement. ...