Pharma

An open letter to Dr. Scott Gottlieb on FDA transparency

Dear Dr. Scott Gottlieb:Scott, on Tuesday you expressed a desire for the FDA to make public a limited number of complete response letters (CRLs) — …

Scott Gottlieb

Merck extends all-important lung-cancer lead with phase 3 Keytruda combo win

Skittish investors grew increasingly concerned last year that Merck & Co. couldn’t replicate a Keytruda-chemo combo's phase 2 success in previously …

Cancer

Will 2018 Be Amgen Inc.'s Best Year Yet?

It would take jumping some really high hurdles.<p><b>Amgen</b> (NASDAQ:AMGN) shareholders had to feel pretty good about 2017. The granddaddy of biotechs saw …

Stocks

'We can't use old models on new innovation': A top GSK says pharma is about to see a massive shift

• <b>Healthcare in the US — from the way it's paid for to the types of drugs that have been approved — has gone through a lot of changes in the past few years.</b>• <b><br>How companies adapt to those changes will be critical to their future, GlaxoSmithKline US pharmaceuticals president Jack Bailey told Business</b> …

Business

Lawmakers weigh measure to fight high drug prices

Lawmakers are considering adding a measure aimed at fighting high drug prices to an upcoming spending deal, in what would be a rare defeat for the …

Amy Klobuchar

The Hot Stock: Merck Gains 5.8%

Shares of <b>Merck</b> (MRK) topped the S&P 500 on Tuesday, helped by upbeat trial results.<p>Merck climbed $3.41, or 5.8%, to $62.07. The S&P 500 slipped <b></b>9.82 …

Stocks

GlaxoSmithKline eyes $1.7B bid for respiratory partner Vectura: report

GlaxoSmithKline already partners with Vectura on respiratory therapies, but some say the British pharma giant could be looking to take the pair’s …

GlaxoSmithKline

Commentary: Why Is Pfizer Giving Up on Parkinson's and Alzheimer’s?

The pharmaceutical company Pfizer (PFE), perhaps best known for its erectile dysfunction drug Viagra, recently announced that it will shut down its …

Parkinson's Disease

In Proposed Regulations CMS Requests Information on Changes to Part D Negotiated Prices

Tara E. Swenson DwyerJurisdiction: All FederalType of Law: Health Law & Managed Care

Law

Roche CEO Schwan concedes challenges as ‘highly, highly profitable’ drugs fall to biosimilar rivals

The risk of biosimilar competition to Roche's top cancer meds prompted one analyst to warn investors to “brace for impact.” Roche CEO Severin Schwan …

Getting Warmer? Valeant’s Pipeline, Reduced Debt Make It Less Risky…But Not a Buy

Shares of Valeant Pharmaceuticals International (VRX) have more than doubled the S&P 500's return during the past 12 months. During that period, the …

Stocks

Brussels gets into drug business

Few topics are more taboo in Brussels than the <b></b>EU getting involved in <b></b>drug pricing.<p>Yet that’s exactly what the European Commission is doing.<p>The …

Brexit

How to sidestep pricing pain? Lean on cancer, not diabetes or inhalers

Good news for pharma's pricing power: The pitched battle over sticker prices is mostly confined to a few therapeutic areas, and drugmakers are …

Eli Lilly

Google, Sequoia back Oxford universal flu vaccine developer Vaccitech

On its way to developing a universal flu vaccine, University of Oxford spinout Vaccitech has raised £20 million ($27 million) in series A financing, …

Public Health

U.S. Biotech/Pharma Sector Daily Observations Letter: January 16, 2018

There was a sharp pullback in the U.S. market indexes due to fear of government shutdown.<p>Eiger Pharma was down close to 50 pct on the surprising …

Business

Roche Achieves Another Milestone With Ocrevus

Roche got an approval for MS drug Ocrevus in Europe.<p>Sales are likely to cross the billion mark this year.<p>Ocrevus has a clean safety profile and the …

Business

Spark's SPK-8011 an Orphan Drug in U.S. for hemophilia A

The FDA designates Spark Therapeutics' (ONCE -1.8%) gene therapy candidate SPK-8011 an Orphan Drug for the treatment of hemophilia A.<p>Among the …

Business

Trump administration drug policy corrupted by campaign cash

Re <i>“</i><i>Sessions targeting pot, not opioids? Crazy.</i><i>”</i> (Jan. 5): Of course Jeff Sessions and Donald Trump are getting tough on marijuana and not doing …

Jeff Sessions

Costco pharmacy directors fined $20,000 after admitting to $1.2-million drug kickback scheme

Costco pharmacy directors solicited more than $1.2 million in unlawful payments, known as rebates, from generic drug manufacturer Ranbaxy, according …

Corruption

Hisamitsu Pharmaceutical Co., Ltd. 2018 Q3 - Results - Earnings Call Slides

The following slide deck was published by Hisamitsu Pharmaceutical Co., Ltd. in conjunction with their 2018 Q3 earnings call.<p>18<p>Click to enlarge

Business

Merck leaps past rivals with latest lung cancer drug results

Merck & Co. Inc. shares surged 7% in extremely heavy trade Tuesday after the company announced that its key cancer drug Keytruda had positive results …

Cancer

Big Pharma’s Alzheimer’s efforts tested by Pfizer’s exit

It has been 15 years since a new drug for Alzheimer’s was launched, reflecting one of the longest and most expensive losing streaks for Big Pharma. …

Alzheimer's Disease

How Ottawa’s using a fake drug crisis to force through damaging pharmaceutical policy

Health policy in Canada is not evidence-based. For proof, look no further than the new drug-price regulations being implemented by the federal …

Cost of Living

Sandoz files U.S. marketing application for Humira biosimilar

Novartis (NYSE:NVS) unit Sandoz submits its U.S. marketing application for its biosimilar to AbbVie's (NYSE:ABBV) top seller HUMIRA (adalimumab). The …

Business

BRIEF-Kiadis Pharma Proposes Subhanu Saxena, Former Cipla CEO, As New Supervisory Board Member

<i>0</i><p>Recent Alerts<p>Sign up to create alerts for Instruments, Economic Events and content by followed authors<p>Free Sign Up<p>Already have an account? Sign …

2018 Strategic Outlook: Will Fortune Favor The Bold In Biotech?

Significant scientific and technological breakthroughs, combined with unabated M&A appetite and tax reform, provide fertile ground for biotech gains …

Business

Benitec's BB-301 an Orphan Drug in U.S. for OPMD; shares ahead 9% premarket

Thinly traded nano cap Benitec Biopharma (NASDAQ:BNTC) is up 9% premarket on light volume in response to its announcement that the FDA has designated …

Business

China’s Medical Representative Registration System: Action Items for Pharmaceutical Companies

Article ByJohn Z.L. HuangDavid DaiMcDermott Will & Emery China Law AlertChina has increased its scrutiny of corruption in the pharmaceutical field …

Health Care

Sanofi to refund Philippines for $28M unused Dengvaxia doses

Facing growing demand from officials and lawmakers, Sanofi Pasteur agreed to refund the Philippine government for unused Dengvaxia doses worth about …

Public Health

Update: Neos Therapeutics Seems To Be Capitalizing On Pfizer's Decisions

In November, I wrote that Neos would likely be the primary beneficiary of missteps by Pfizer and Noven.<p>Pfizer's issue with Quillivant is active, and …

Business