Researchers say Tamiflu a waste of money

Complete data sets have prompted researchers to say Tamilflu and Relenza fail at their key reason for being: preventing flu pandemics.

Merck looks poised to challenge Gilead

Merck looks poised to challenge Gilead

Phase-II results indicate Merck's all-in-one HCV oral could put pressure on Gilead.

Halozyme pancreatic drug study on FDA hold

Halozyme pancreatic drug study on FDA hold

The FDA issued an official halt, five days after Halozyme stopped the Phase-II trial because of patient stroke information.

Louisiana sends Takeda $9-billion Actos bill

The drugmaker is accused of burying cancer risks associated with the diabetes medication.

FDA won't review Afrezza until July

The regulator has put off the inhaled insulin's PDUFA date by three months.

Alkermes to submit schizophrenia med this year

Phase-III results prompted the drugmaker to pursue a third-quarter filing.

Sun Pharma to buy Ranbaxy

The announcement will create the fifth largest generics drug maker, reports Reuters.

Roche seals two deals in one weekend

The Swiss drugmaker has scooped up Oryzon's experimental acute myeloid leukemia treatment and private Massachusetts diagnostics firm IQuum.

GSK reportedly being investigated for Mideast behavior

WSJ's sources say allegations of misconduct are similar to those leveled against the company in China.

ViiV adds Tivicay to UN patent pool

The GSK-Pfizer-Shionogi joint venture said it will add HIV med Tivicay to a United Nations patent pool, cutting its price for developing countries and granting access for generics firms.

GSK stops lung-cancer vaccine trial

The drugmaker is ceasing a trial called MAGRIT after it was unable to identify patients who could benefit from MAGE-A3.

Compounders get version of PDUFA

The FDA has issued draft guidance that funds FDA inspection of some drug compounders.

SCOTUS to hear out Teva on Copaxone delay

The Israel-based drugmaker will try to extend the MS treatment's patent life until September 2015.

Lilly Alimta patent extended to 2022

Lilly Alimta patent extended to 2022

A court granted Lilly six more years of patent protection for the almost $3-billion-dollar-a-year cancer drug.

In DC, parties argue generic label freedom

In DC, parties argue generic label freedom

At a hearing today, Public Citizen and the generics industry are sounding off on an FDA proposal that would allow generics firms to update labels, regardless of whether the brand has or hasn't.

New OTC Nexium approved

The FDA has approved a 24-hour version of Pfizer's heartburn medication.

J&J gets out of diagnostics

The Carlyle Group has picked up Johnson & Johnson's Ortho Diagnostics for $4B.

Massachusetts bans Zohydro

The Bay State is saying no to the controversial prescription painkiller.

Amgen's PSCK9 shows rare disease potential

Amgen's PSCK9 shows rare disease potential

The Thousand Oaks, Calif. company says its cholesterol-lowering antibody hit its clinical trial endpoint among rare disease patients.

Possible Zohydro competitor surfaces

Possible Zohydro competitor surfaces

A rival's late-stage trial results suggest the pain med may have a short market life. The key: an FDA division head's documented willingness to overturn the approval should another pain option surface.

Celebrex patent loss to inflict EPS pain, but little more

Celebrex patent loss to inflict EPS pain, but little more

Analysts indicate the earlier-than-expected patent loss will not be a significant upset to Pfizer's present. The drugmaker plans to appeal the decision.

Nexavar fails recurrence target

Nexavar fails recurrence target

Bayer and Amgen's Onyx subsidiary announce an oncology drug failed a Phase-III trial goal among liver cancer patients.

Biogen, Eisai in Alzheimer's pact

Biogen Idec and Eisai said they will collaborate on and co-market two of Eisai's clinical candidates for Alzheimer's disease.

Sanofi seeks to revive Kynamro launch

Sanofi seeks to revive Kynamro launch

Kynamro's slow start, coupled with competition, has prompted Sanofi to add sales reps.

Bayer acquires Chinese consumer co.

Bayer bought China-based Dihon Pharmaceutical Group, which specializes in traditional Chinese medicine consumer goods.

Ranbaxy shuts two sites

The drugmaker says the voluntary measure was out of an abundance of caution.

FDA seeks flexible OTC review process

The agency says is it time to update the onerous decades-old review process.

Forest acquisition whets M&A appetite

Bloomberg reports that Teva has sparked interest as a takeover target.

Industry wary of new German pricing rule

Germany's price transparency requirement has the industry worried other markets will demand lower prices.

Actavis buys Forest, bolsters specialty biz

Actavis buys Forest, bolsters specialty biz

The drugmaker, hitherto known for its generic expertise, says the purchase could mean that half its future revenue will come from branded, specialty drugs.

Merck latest rival in race to copy Lantus

Merck latest rival in race to copy Lantus

Merck announced this week that its insulin glargine biosimilar, being developed with Samsung and Biogen Idec, would soon enter Phase-III trials.

Novartis to rein in pharma costs

Novartis to rein in pharma costs

The CEO told Leerink analysts the pharma business needs better margins, not unfettered R&D budgets.

Pharma M&A activity rebounds in 2013: report

Pharma M&A activity rebounds in 2013: report

Driven by a number of high-profile buys in 2013, pharma saw a return to investment through acquisition after a 2012 dip.

AbbVie sets up shop in Singapore

The new manufacturing site will be its first in Asia.

FDA panel to review NSAIDs this month

A panel is meeting February 10 to discuss revoking the OTC status of some medications.

Sanofi sues to protect Lantus

The suit stalls Eli Lilly's biosimilar version of insulin glargine.

AstraZeneca closes India R&D shop

168 employees will be pink-slipped this quarter.

Amgen revenue rose, but '14 sales could slip

Amgen 2013 revenues increased by 17% from 2012 to $18.7 billion, the company reported, but it faces headwinds in 2014 for older meds.

Watershed year ups expectations for Biogen

Watershed year ups expectations for Biogen

Taken to new heights on the launch of MS blockbuster Tecfidera, the drug maker has raised its 2014 forecast.

Novartis pharma sales held steady in 2013

Novartis pharma sales held steady in 2013

Generics took a $2.2-billion bite out of sales, but growth products like Gilenya helped to minimize the impact.

Actavis sells Foshan Pharma stake

The news follows company statements that China is not business friendly.

Sovaldi launch trounces Incivek's

Prescription data shows Gilead's Sovaldi is winning prescriptions at a faster rate than Vertex's Incivek did at launch.

Novartis lays off 500 pharma staff

The company will be beefing up support of Sandoz, its generics division.

IMS researchers urge pharma to get social

IMS researchers urge pharma to get social

The latest IMS report shows that 50% of the top 50 pharma companies are not on social media. Executive Director Murray Aitken tells MM&M it is to pharma's detriment.

AZ on evolutionary cusp, analyst says

AZ on evolutionary cusp, analyst says

Analyst Seamus Fernandez, of Leerink Partners, says the drugmaker is set to be a considerable immuno-oncology and respiratory presence.

Novartis oncology head goes to Incyte

Herve Hoppenot changed jobs overnight.

Lilly buys migraine antibody

The company bought rights to a Phase-II drug for recurrent migraine headaches.

Dept. of Justice subpoenas Aegerion

Dept. of Justice subpoenas Aegerion

The drugmaker announced Friday that the DOJ wants documents regarding sales and marketing of Juxtapid, its drug for an ultra-rare lipid disorder.

Merck and Novartis rumored to swap assets

An insider says Merck may be up for trading its OTC business for Novartis's animal health business, but the benefits for either side may be better on paper.

Teva names new CEO

Erez Vigodman will be Teva's president and CEO as of February 11.

Patent cliff a drag on 2012 health spend

Patent cliff a drag on 2012 health spend

Generics accounted for almost 75% of dispensed drugs in 2012, according to CMS researchers.

Antidepressants may have to fight for Part D coverage

CMS is proposing a rule that could change how antidepressants get on Medicare Part D formularies.

GSK, Celgene cough up milestone payments

Cambridge, MA-based Epizyme claimed $29 million in milestone payments from the two drugmakers.

2014 shaping up to be bridge year for Lilly

2014 shaping up to be bridge year for Lilly

The company's guidance aligns with expectations that 2014 will be a nail-biter.

Iclusig is back in US

Iclusig is back in US

Two months after it was pulled from the US market, Iclusig is returning with a narrower approval.

Bayer buys Algeta

The $2.9 billion deal means Bayer owns prostate cancer drug Xofigo in full.

Sanofi, Regeneron PCSK9 trial uses new recruitment tool

The American College of Cardiology is contributing its Pinnacle registry to identify clinical trial patients.

BMS breaks free of diabetes

BMS breaks free of diabetes

BMS is giving up its stake of the AstraZeneca diabetes joint venture for $2.7 billion up front, and future milestone payments.

Teva, Pfizer settle on Viagra generic date

Teva said a settlement will allow it to sell a copy of the blockbuster ED pill prior to the official LOE.

Biogen Idec pursues anti-TNF biosimilars

Biogen Idec pursues anti-TNF biosimilars

Biogen Idec and JV partner Samsung are going into the biosimilars business.

FDA's 2013 so far: 26 approvals

FDA's 2013 so far: 26 approvals

The FDA's Center for Drug Evaluation and Research released a preliminary year-in-review report that says the agency has cleared 26 new molecular entities this year.

Lundbeck, Otsuka collborate on Alzheimer's

Vaccine LU AF20513 is the their third Alzheimer's collaboration.

Teva unclear on 2014 future

The company released two financial scenarios. The key is generic Copaxone.

Covidien buys firm armed with missile tech

Covidien is buying ingestible-camera company Given Imaging.

FDA greenlights Gilead's sofosbuvir

FDA greenlights Gilead's sofosbuvir

The drug is priced at $28,000 a month, before add-ons like ribavirin and (possibly) interferon.

Lilly dustbins edivoxetine depression indication

The drug failed to hit its Phase III targets.

Another study about doctor-patient divide

Novo's global diabetes study finds that only 29% of polled patients were asked what they thought about prescribed regimens.

Polls highlight chronic disease information needs

Polls highlight chronic disease information needs

Chronic disease patients seek online support and information, and show little love for branded websites.

Forest, Eisai announce slim-downs

Forest's cost-savings initiative is aimed at reducing operating expenses by $500 million, while Eisai said it's cutting 130 positions in the US and Europe.

Genetics and a dig at rivals for the holidays

Spectrum DNA says its genetic services are at the ready, even if 23andMe's are not.

Europe says Ariad's Iclusig can stay

The leukemia drug is staying on the market, but for a more restricted patient population.

Orexigen could enter weight-loss race June 2014

Orexigen could enter weight-loss race June 2014

The drugmaker says interim trial data meets FDA review requirements and is hoping for June 2014 approval.

Layoff season continues

Actavis shrinks its staff by 30%, and Bayer reduces its California footprint.

OPDP letter dings Kadmon for previous violation

OPDP letter dings Kadmon for previous violation

The agency's bad-ad warning letter calls the new violations "particularly troubling."

FDA panel backs BioMarin rare-disease drug

FDA panel backs BioMarin rare-disease drug

The patient population is small, at around 3,000, but the expected price tag is $330,000 a year.

Merck releases early PD-1 melanoma data

Early clinical trial results indicate 81% of advanced melanoma patients survived for one year.

IMS predicts $1T global drug market by 2017

IMS predicts $1T global drug market by 2017

The catch is the difference between sales and revenues. Generics will continue to be a force, and small-audience drugs will become increasingly important.

GSK's Breo approved in Europe, COPD market may be underestimated

GSK's Breo approved in Europe, COPD market may be underestimated

Known as Breo Ellipta in the US, GlaxoSmithKline's Relvar Ellipta was approved by the EMA for asthma and COPD. The overall market is expected to continue to grow, but an NIH study indicates more patient conversations need to happen.

Alexion recalls some Soliris batches

The US-only recall amounts to less than 1% of the company's inventory.

Report: J&J nearing hip settlement

The current number is reported to hover around $4 billion.

Dendreon reorganizes, tries to keep sales reps

Dendreon reorganizes, tries to keep sales reps

The company says it will cut staff and costs, focus on big accounts and try to keep sales reps from leaving.

GSK misses on late-stage CV drug

GSK misses on late-stage CV drug

An investigational cardiovascular heart drug failed to reduce the risk of heart attack or stroke, a miss which some on Wall Street say raises questions about the drugmaker's ability to deliver in late-stage trials.

Ariad workforce shrinks by 40%

The company announced the layoffs Friday.

TV interviews trigger Aegerion warning letter

TV interviews trigger Aegerion warning letter

The FDA's Bad Ad group says the drugmaker misbranded its cholesterol drug during interviews on CNBC.

BMS narrows its R&D focus

BMS narrows its R&D focus

The company's pursuit of a tighter research focus follows a path very much like that of its peers.

Many unclear on 2013 Sunshine data

Many unclear on 2013 Sunshine data

A poll by consulting firm QPharma indicates doctors are in the dark about what needs to be reported and what will be revealed.

Vivus slims down in wake of sluggish sales

Vivus slims down in wake of sluggish sales

The drugmaker says 20 jobs, or 17% of its workforce, will be gone by the end of the year.

Endo swallows Paladin for $1.6B

The "New Endo" will be one company on the outside, two on the inside.

Novartis to lay off 371 in UK

The news is part of an ongoing reorg by the Swiss firm that is rumored to include selling off its animal health business.

As HIV meds mature, Gilead preps for HCV launch

As HIV meds mature, Gilead preps for HCV launch

A 15% increase in sales came on the back of HIV franchise meds Stribild and Complera/Eviplera.

Teva denies rumors of CEO-board friction

Generic giant Teva refuted allegations that the CEO, Jeremy Levin, and the board of directors were at odds over the company's cost-saving maneuvers.

Vertex lays off 370, focuses on cystic fibrosis

The company's hep. C drug Incivek peaked in 2011. Competition and pipeline drugs have forced the company to regroup.

Report: Dendreon looking for buyer

The prostate cancer drug company is reportedly seeking a buyer to turn things around.

Tecfidera sales soar, cannibalize older med

Tecfidera sales soar, cannibalize older med

Based on its first three months on market, Tecfidera is one launch that's living up to its hype.

Eisai loses DEA battle

A court refuses to compel a government agency to schedule the firm's epilepsy drug, as the med's patent clock ticks.

Merck seeks way to stem sales slide

Merck seeks way to stem sales slide

The company says it is moving its Januvia sales pitch from defending market share to expanding it.

Back-to-school sales blitz boosts Vyvanse

Back-to-school sales blitz boosts Vyvanse

Vyvanse was one of six drugs with double-digit revenue increases, propelling sales of the specialty drugmaker Shire up 13% for the quarter.

Earnings roundup: Amgen, GSK, Forest, Novartis

A roundup of firms' quarterly performance culled from sources around the web.

Lilly's winning the DPP-4 duel with BMS

Lilly's winning the DPP-4 duel with BMS

Amid talk of cost containment, Lilly said it's also enjoying nice returns from some of its older diabetes drugs.

Good news/bad news for Merck's pipeline

Word came of Breakthrough Designation for an HCV hopeful, a day after a hiccup in a heart drug trial.

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