Lawmakers float generic drug legislation

The bill proposes fining branded drugmakers for not complying.

Auxilium turns down Endo, leaves door open

Auxilium turns down Endo, leaves door open

The Chesterbrook, PA, drug manufacturer announced Monday Endo's unsolicited $2.2-billion bid undervalued the company.

Five things for pharma marketers to know: Monday, September 22

Five things for pharma marketers to know: Monday, September 22

GSK releases polio-infected water into Lasne River in Belgium; House reps Burgess and Schwartz introduce CME exemption bill for Sunshine Act; NIH and FDA announce plan to create facebook-esque catalogue of oral-drugs.

Five things for pharma marketers to know: Friday, September 19

Five things for pharma marketers to know: Friday, September 19

Lilly's weekly GLP-1 shot is approved, BI expands its lung-cancer portfolio, GSK's China investigation closes, NY proposed Sovaldi triage and India imposed price limits on 36 new medicines.

Missing generic hurts Rite Aid

The drugstore chain has lowered its forecast, and generics are just one reason.

Novartis NY layoffs coming

Plans to unwind the Suffern, NY, site move forward this winter.

Merck's weekly DPP-IV on par with daily Januvia: study

Merck's weekly DPP-IV on par with daily Januvia: study

Merck unveiled the DPP-IV clinical trial results at the European Association for the Study of Diabetes Annual meeting Thursday.

Endo makes $2.2B bid for Auxilium

Endo makes $2.2B bid for Auxilium

Endo's timing also comes as Auxilium has committed to reorganizing and merging with Canada's QLT.

DOJ eyes Ranbaxy pricing

The Department of Justice is looking into Medicaid pricing.

Switzerland wants lower drug prices

Switzerland is pushing Roche to lower its prices on Perjeta

Five things for pharma marketers to know: Wednesday, September 17

HealthKit off to a bumpy start; Endo offers $2.2 billion for Auxilium; Gilead advanced pancreatic cancer drug fails in trial.

BMS striving to push Opdivo past Keytruda

BMS striving to push Opdivo past Keytruda

Keytruda was the first of the new PD-1 class of immuno-oncology drugs to reach the US, but Bristol-Myers Squibb and Ono could run away with the competition, according to one analyst.

Merck osteoporosis drug does not wow

Merck osteoporosis drug does not wow

Analysts do not expect odanacatib to be a major earner.

Regeneron's Eylea scores Breakthrough label

The designation is for diabetic retinopathy for patients with diabetic macular edema.

AbbVie, Biogen to file MS drug next year

AbbVie, Biogen to file MS drug next year

Phase-III results of the AbbVie-Biogen Idec experimental multiple sclerosis shot Zinbryta (daclizumab) indicate the drug bests Avonex (interferon beta-1a) on some measures among relapse-remitting MS patients.

Takeda backs Contrave with 900 sales reps

Takeda backs Contrave with 900 sales reps

Takeda's Director of Obesity Marketing Katie Andino told MM&M in a phone interview that the drugmaker will be taking a unique approach to woo patients, physicians and payers.

Liraglutide, aiming for new indication, gets new name

Liraglutide, aiming for new indication, gets new name

Why Novo Nordisk is choosing not to leverage Victoza's brand equity as it seeks a weight-loss indication for liraglutide.

Xtandi duo boosts rep force for pre-chemo push

Xtandi duo boosts rep force for pre-chemo push

With its label extended to the pre-chemo setting, the prostate cancer drug is poised to reach a new group of urologists, and could upend J&J's Zytiga.

Sanofi wants greater MS role

The plan is to bring in-house products to the market as well as through acquisitions.

BI Spiriva combo has Phase-III success

BI Spiriva combo has Phase-III success

The company said in a statement that the findings indicated the Spiriva-Striverdi combination treatment could help patients "return to a more independent life."

Lilly basal bests Lantus in T1D, despite safety concerns

Lilly basal bests Lantus in T1D, despite safety concerns

Lilly's long-acting insulin showed it's more effective in type 1 diabetics than Lantus, but concerns about its overall profile persist.

FDA sanctions don't kill a business

Bloomberg reports that India's Wockhardt has become an M&A target.

Pfizer, Novartis ink respiratory deal

Pfizer will sell two Novartis drugs in the UK.

Roche to lay off 100, restructure

Sales reps are among the pinked-slipped in Spain.

New lipid agents are high on potency, low on doc awareness

New lipid agents are high on potency, low on doc awareness

The new PCSK9 class of cholesterol-lowering antibodies continues to look promising, but many doctors—particularly PCPs—have never even heard of the experimental drugs.

FDA lifts OncoMed partial hold

The FDA froze the clinical trial of anti-Fzd7 vantictumab in July over concern about "bone-related adverse events."

Research links estrogen and binge eating

Baylor College of Medicine researchers have found that an estrogen replacement suppressed binge-eating behavior among lab mice.

Novartis may have game-changing drug

Novartis may have game-changing drug

Key opinion leaders indicate they are ready to embrace Novartis's experimental heart failure medication LCZ696. Such a move could upend heart failure treatment protocols.

Lilly takes on Amgen's Enbrel

Lilly takes on Amgen's Enbrel

Phase-III tests indicate Lilly's experimental treatment bests Amgen's for moderate-to-severe plaque psoriasis.

GSK Ellipta franchise expands

GSK Ellipta franchise expands

The FDA has approved Arnuity Ellipta for asthma.

Amicus seeks to upset Fabry market

Amicus seeks to upset Fabry market

Phase-III tests indicate patients may be able to switch from injectable enzyme-replacement therapies, like Fabrazyme, to the firm's oral drug.

DOJ closes Brilinta investigation

AstraZeneca announced the end of the investigation Tuesday.

Kyprolis fails to wow in survival trial

Kyprolis fails to wow in survival trial

Amgen now hopes a separate study will be enough to support the drug's advancement to a second-line therapy, but the lackluster results may impinge on its EU filing schedule.

InterMune joins M&A fray

GlaxoSmithKline, Actelion, Sanofi and Roche are said to be among a host of suitors.

Boehringer to cut costs by 15%

Layoffs are reported to be in the offing.

Kyprolis data fuel Amgen oncology aspirations

Kyprolis data fuel Amgen oncology aspirations

Blood-cancer drug Kyprolis outperformed standard treatment in a late-stage trial testing the drug in patients with multiple myeloma, said Amgen.

Sanofi tightens PCSK9 race, exceeds Q2 expectations

Sanofi tightens PCSK9 race, exceeds Q2 expectations

Sanofi and partner Regeneron attached a $67.5-million priority review voucher to their experimental cholesterol drug alirocumab, making for a tighter race with Amgen.

J&J pulls morcellator from market

The company is calling the move a withdrawal, as opposed to a recall.

Pfizer buys two Baxter vaccines

The meningitis and encephalitis medications earned a combined $300 million last year.

Social media perceived as clinical trial risk

The Wall Street Journal reports that patients are sharing a plethora of information about their clinical trial experiences, from how to get picked, to how to figure out who is in a control group.

AstraZeneca beefs up respiratory portfolio

AstraZeneca beefs up respiratory portfolio

AstraZeneca has made an $875-million move to beef up its respiratory pipeline by making Almirall's lineup its own.

Amgen Q2 sales rise, company to lay off up to 2,900

Amgen Q2 sales rise, company to lay off up to 2,900

The majority of the layoffs will be in the US.

Pfizer Q2 sales slip, but still beat expectations

Pfizer Q2 sales slip, but still beat expectations

Patent losses and lost co-promotion agreements put a dent in sales.

GSK refutes consumer spin-off rumor

The company refutes a Financial Times rumor that one was happening soonish.

Study questions HDL medication benefit

A study indicates they may do little to reduce the risk of stroke or heart attack.

Lack of marketing partner delays Afrezza launch

Lack of marketing partner delays Afrezza launch

Afrezza was heralded as one of the most innovative diabetes products of the last decade. So, why hasn't MannKind set a firm launch date for the product?

Bayer's Nexavar disappoints in breast cancer

The drug did not hit its Phase III primary target of improving progression-free survival.

Gilead, Merck HCV marketing battle may be on horizon

Gilead, Merck HCV marketing battle may be on horizon

Disclosed in its earnings report yesterday, Gilead may have a card up its sleeve to counter Merck's experimental hep. C combo regimen.

Sales of Biogen MS pill pick up overseas

Sales of Biogen MS pill pick up overseas

Biogen Idec is seeing strong sales for blockbuster MS drug Tecfidera, especially overseas where it's beginning to catch fire this summer.

Shire expands rare disease reach

A $225-million deal with US biotech ArmaGen gives Shire worldwide commercialization rights to an experimental enzyme replacement therapy.

GSK second-quarter sales disappoint

GSK second-quarter sales disappoint

Executives urge analysts to focus on the company's long-term potential.

NIH: HPV test beats Pap for cancer assessment

HPV testing provides an edge over Pap screenings when it comes to detecting cervical cancer risk.

Roche is hungry, not starving for M&A

CEO Severin Schwan tells Reuters that the Swiss firm will be looking for small acquisitions and partnerships.

Allergan touts reorg, plans to lay off 13% of workforce

Allergan touts reorg, plans to lay off 13% of workforce

Allergan's second-quarter earnings, and a new round of cuts, are now part of the Botox maker's record as it seeks to remain independent.

Shire, AbbVie join forces for $55B

Shire, AbbVie join forces for $55B

The deal includes a $1.6-billion fee if AbbVie tries to walk away.

Next target for hep. C drugmakers: co-infections

Next target for hep. C drugmakers: co-infections

An international AIDS conference this weekend kicked off a new battle in the war against hepatitis C: demonstrating high cure rates in those who are co-infected.

AbbVie nabs Shire for $54B

AbbVie, in the latest example of a US drugmaker seeking to lower its tax rate, said today that it's buying Dublin-based Shire for $54 billion.

Biogen poised to shake up hemophilia market

Biogen poised to shake up hemophilia market

Less-frequent dosing and competitive pricing could spur a shift in market share among products that treat the hereditary blood disorder.

J&J logs $19.5B in Q2 sales

J&J logs $19.5B in Q2 sales

Hepatitis C medication Olysio was a star, but the company cautions competition is coming.

Roche seeks Avastin cervical-cancer indication

Roche seeks Avastin cervical-cancer indication

The FDA granted Priority Review for consideration of Avastin for some cervical-cancer patients.

Advocacy group alleges Sanofi-Shire conspiracy

An advocacy group alleges that Shire's decision to ignore the US Fabry disease market was the result of a backroom deal with Sanofi.

Alzheimer's study to use healthy patients

Novartis and the nonprofit Banner Alzheimer's Institutes are testing a theory that treating healthy patients could prevent or delay Alzheimer's disease.

Shire asks AbbVie for more money

Shire asks AbbVie for more money

Shire and AbbVie's courtship has entered round five. A deal would offer AbbVie tax relief, and possibly make it an acquisition target.

Abbott pairs generics with tax benefit

Abbott and Mylan are setting up a generics business. The all-stock deal will give some branded generics a new home and offer Abbott a tax benefit that will increase over time.

Lilly's Cyramza misses liver-cancer target

Cyramza patients had more favorable overall survival rates than placebo patients, but the differences were not statistically significant.

Senators press Gilead over Sovaldi price

Senators press Gilead over Sovaldi price

In the latest chapter in the Sovaldi pricing saga, Senators Ron Wyden and Charles Grassley urge Gilead to clarify Sovaldi sticker shock.

Allergan trims fat to halt takeover

Allergan will implement company-wide cost-cutting maneuvers, Bloomberg reports, to keep Valeant at bay.

AbbVie ups ante in Shire takeover bid

AbbVie ups ante in Shire takeover bid

Two weeks after its $46-billion bid was shot down, AbbVie has revised its offer in hopes of opening up negotiations with Shire.

Lilly, Yabao collaborate on diabetes

The companies will develop Lilly's glucokinase activator LY2608204.

Sun recalls cancer drug

It's the generics maker's second recall of 2014.

Study unlinks testosterone and heart attacks

The Wall Street Journal notes that a new study on testosterone therapy has some weaknesses, including its sole focus on men who received injections—leaving out pills, patches and gels.

Study links DPP-IV medication to heart failure, hospitalization

Editorial says risk is small, researchers say it could be clinically relevant.

Zohydro's second act

Zogenix is working on a less easily abused formulation of its controversial prescription painkiller.

France ponders off-label Avastin

French lawmakers have the chance to vote for off-label use of Avastin, potentially eating into the turf of higher-priced Lucentis.

BI drug gets priority review

Boehringer Ingelheim's experimental idiopathic pulmonary fibrosis treatment nintedanib is also an orphan drug.

India's generics makers hire Beltway help

The Indian Pharmaceutical Alliance makes a bid for legislators' attention.

ACP says no need for pelvic exams

The American College of Physicians says most women do not need an annual pelvic exam. The American College of Obstetrics and Gynecologists disagrees.

Allergan updates pipeline

Allergan updates pipeline

Allergan's latest pipeline news was a mix of the good and the bad. The good: a potential Lucentis competitor is progressing. The bad: migraine medication Semprana has stalled.

MannKind's Afrezza approved

MannKind's Afrezza approved

The FDA approved the inhaled insulin last week.

FDA wants male breast cancer patients

The regulator wants men to be part of breast cancer clinical trials.

Diovan competition is coming

Novartis no longer has a lock on the Diovan market: the FDA approved Ranbaxy's generic, which will be made in the US.

Auxilium merges with Canadian biotech in tax-inversion effort

Pennsylvania drugmaker Auxilium will merge with Vancouver-based biotech QLT to lower its corporate tax rate.

Panel votes against AZ's olaparib

Panel votes against AZ's olaparib

An FDA advisory panel voted 11-2 against an accelerated approval for AstraZeneca's experimental PARP inihibitor. The panel recommends getting more data before giving the drug the all-clear.

BMS cuts nivo' trial short, eyes approval pathway

BMS cuts nivo' trial short, eyes approval pathway

The firm ended the Phase III trial for its ballyhooed immunotherapy, which showed superior survival compared to chemo in advanced melanoma.

Vyvanse patent win bolsters Shire as AbbVie circles

Certain claims of the patents protecting the ADHD drug were both infringed and valid, a court ruled, giving Shire a boost as it contends with a takeover bid by AbbVie.

Novo issues bullish sales forecast

The firm said it expects to more than double its revenue within the decade, as the surging incidence of diabetes expands demand for its products.

Expanding weightloss drug doesn't wow

An experimental Gelesis weight-loss drug seeks the middle ground between surgery and appetite suppressants.

Vertex to submit CF drug combo to FDA this year

Vertex to submit CF drug combo to FDA this year

Phase III results showing improved lung function among cystic fibrosis patients using a combination of Kalydeco and lumacaftor means drugmaker Vertex is filing the two-part drug for FDA approval during the fourth quarter.

Shire rebuffs AbbVie

Dublin-based Shire is urging shareholders to back independence and ignore AbbVie's $46.4 billion bid.

BI calls it quits in hep. C

BI says there is no unmet need for faldaprevir.

Marketing tone sinks GSK recruiter

GlaxoSmithKline dismissed a marketer over its approach to clinical trial recruiting.

Triglycerides, not HDL, may be cardio bad guys

Gene mutations lead researchers to rethink ways to protect the heart.

Clinical researchers dip toe into social media

Clinical researchers dip toe into social media

Researchers are increasingly using social media to recruit patients, albeit oftentimes in an arms-length manner.

Lilly, BI resubmit diabetes medication

The companies resubmitted SGLT2 inihibitor empagliflozen for FDA review. The EC approved the drug in May.

Takeda walks away from Omontys

The drugmaker is pulling its US marketing application for the anemia drug.

Medtronic buys Covidien

The deal makes Medtronic the most recent company to seek out lower tax rates.

Novartis says it buried studies

The drugmaker has told global regulators it failed to share 10,000 reported cases of side effects for a variety of its drugs.

Higher dose of Victoza helped patients drop weight

Higher dose of Victoza helped patients drop weight

Patients taking a high-dose form of Novo Nordisk diabetes drug Victoza saw an average weight loss of 5.9% of their body weight, data from a study show.

Pfizer says money killed AZ deal

CFO Frank D'Amelio told an investors conference AstraZeneca wanted more money.

Allergan turns down Valeant

CEO David Pyott told Modern Healthcare that acquisition fallout would have probably included a pinched R&D budget and higher product prices.

Email Newsletters

MM&M EBOOK: PATIENT ACCESS

Patient access to pharmaceuticals is a tale of two worlds—affordability has improved for the majority, while the minority is hampered by cost, distribution and red tape. To provide marketers with a well-rounded perspective, MM&M presents this e-book chock full of key insights. Click here to access it.