The Cross-Border Biotech Blog

Biotechnology, Health and Business in Canada, the United States and Worldwide

Tag Archives: Wyeth

Dreaming of REMS: A Second Reason Why FDAAA Risk Evaluation and Mitigation Strategies Might Be a Benefit to Drug Developers

Over at The In Vivo Blog, Michael McCaughan has another thought-provoking piece on REMS — the FDA’s Risk Evaluation and Mitigation Strategies that impose tight controls on the distribution channels for certain drugs. Michael compares two drugs for the same indication — opioid-induced constipation therapy, if you must know — and though they have similar [...]

Corporate Liability Journal Article on Wyeth v. Levine, Reigel v. Medtronic and Medtronic v. Lohr

Check out Jeremy’s latest article, published in the current issue of Corporate Liability Journal. In The Changing Landscape of U.S. State Tort Liability for FDA-Approved Drugs and Medical Devices (pdf), Jeremy and his co-author, Alison Varga, take a more detailed look at this year’s U.S. Supreme Court decisions in Wyeth v. Levine and Reigel v. Medtronic, which Jeremy [...]

Post-Vacation Brain Dump: Deal Developments

Some exciting deal news from the week: Neuromed, which licensed U.S. rights to its lead candidate Exalgo to Mallinckrodt after Merck dropped out, entered into an interesting stock-for-stock merger deal with Cambridge, MA-based CombinatoRx that we’ll discuss further in this coming Monday’s deal review. Paladin Labs made a deal with Wyeth for a bundle of products that [...]

Wednesday Brain Dump: Two of Everything! Edition

Two Camels!  Dolly the cloned sheep, meet Injaz the cloned camel. Two R&D Heads!  The combined Pfizer-Wyeth will have Mikael Dolsten heading up the newly created BioTherapeutics Research Group and Martin Mackay heading up the small molecule PharmaTherapeutics Research Group.  (Two CapitalLetters!)  The In Vivo Blog has a podcast interviewing both. Two VA Initiatives!  In addition to the electronic [...]

Monday Deal Review: April 6, 2009

One complex arrangement, two clinical trial updates, three commercial deals and other bits of Canadian deal and company miscellany

Preemption Update: Waxman and Pallone Hit the Ground Running

When we reported on the Supreme Court’s decision in Wyeth v. Levine, we wondered what the effect would be on legislation proposed by Reps. Waxman and Pallone.  We did not have to wonder long — they introduced legislation yesterday, with a parallel effort from Sens. Kennedy and Leahy, to moot the Supreme Court’s decision in Reigel v. [...]

Supreme Court Rules 6-3 Against Preemption in Wyeth v Levine

The Wyeth v. Levine opinion (pdf) was handed down this morning, holding that state tort law claims (in this case, inadequate warning) are not preempted by the FDCA.  Justice Thomas’ concurring opinion starts at page 30 of the pdf.  Alito and Scalia’s dissent starts at page 54 of the pdf. Now we have different preemption rules for [...]

More Waxman-Pallone Reporting on State Tort Liability, Preemption, Medical Devices and FDA Approval

The NY Times Business section (and the WSJ Health Blog) this morning picked up the story — that we noted last week – that Waxman and Pallone plan to reintroduce legislation essentially reversing the Supreme Court’s ruling in Reigel v. Medtronic.  Those stories also note a Senate version to be introduced by Sen. Kennedy and Sen. [...]

Rep. Waxman, Reigel v Medtronic and Wyeth v Levine

Last Summer, the U.S. Supreme Court held in Reigel v. Medtronic that the premarket approval (PMA) process for medical devices pre-empts liability under State common law for claims challenging the safety or effectiveness of medical devices.  Wyeth v. Levine, which the U.S. Supreme Court heard last Fall, but has not decided, makes a parallel argument with [...]

It’s Raining M&A: Update

Canadian developments first: MDS (TSX:MDS; NYSE:MDZ) announced that it’s forming a special committee to “support the Company’s continuing process of reviewing alternatives to improve shareholder value.”  According to the press release: The committee is comprised of William Anderson, Robert Luba, James MacDonald and Gregory Spivy, each of whom is independent of management. James MacDonald will [...]

It’s Raining M&A

Pfizer-Wyeth is certainly the biggest headline (see here for info on those companies in Canada), but it seems like a very popular time to be shopping.

Pfizer-Wyeth in Canada

Following today’s developments, some Canadian stats from the Pfizer Canada and Wyeth Canada web sites:

Follow

Get every new post delivered to your Inbox.

Join 84 other followers