Five things for pharma marketers to know: Thursday, August 21

Five things for pharma marketers to know: Thursday, August 21

An Ebola survivor is set to leave Emory University Hospital, but the cause of the cure is uncertain, the FDA has approved a new type 1 diabetes test, and the latest in the Allergan-Salix battle.

Sanofi expands Gaucher disease portfolio

Sanofi expands Gaucher disease portfolio

The oral medication Cerdelga joins Cerezyme in its Gaucher disease arsenal. Sanofi expects the drug will be priced "on par" with Cerezyme, which goes for around $300,000 a year in the US.

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.

Allergan reported to seek out Salix deal

The Wall Street Journal says the deal would add "another layer of intrigue" to the Allergan-Valeant hostilities.

India's Marck gets FDA Warning Letter

Inspectors of Marck Biosciences found an array of problems during a October-November 2013 inspection, including mold near a sterile area that was so bad "the room had 'partially caved in.'"

Five things for pharma marketers to know: Wednesday, August 20

Five things for pharma marketers to know: Wednesday, August 20

Novartis explores the virtual care space, a court has dismissed a lawsuit against IPAB, Doctors Without Borders calls the Ebola outbreak "a complete disaster" and Pfizer becomes the first pharma company to pair with the Crohn's and Colitis Foundation of America.

FDA kind of OKs Lilly/BI's Lantus look-alike

FDA kind of OKs Lilly/BI's Lantus look-alike

Sanofi's patent lawsuit triggered the tentative approval of the Lilly-BI Lantus competitor.

GSK relaunches COPD.com

GSK relaunches COPD.com

The refresh launched soon after the company encouraged investors to take a long view of GSK as the firm posted weak respiratory numbers.

DOJ closes Brilinta investigation

AstraZeneca announced the end of the investigation Tuesday.

Doctors back unique biosimilar names

A host of doctors has asked FDA Commissioner Margaret Hamburg to back a naming convention that would require biologics and biosimilars to have different names.

Six things for pharma marketers to know: Tuesday, August 19

Six things for pharma marketers to know: Tuesday, August 19

Lilly/BI receives tentative approval for insulin biosimilar; Ebola death rate hits new high; LaMattina sounds off on Pfizer's oncology efforts; art therapy becoming the norm in hospitals.

Roche has no rights to Sovaldi, panel rules

Despite a collaboration with original Sovaldi owner Pharmasset in 2004, a panel ruled Roche has no rights to HCV treatment Sovaldi.

Eisai sues FDA for more patent life

The Japanese drugmaker is looking to add as much as a year onto the patent life of some of its drugs after the DEA dragged out their scheduling decisions.

Doctors do not care about your Fitbit

Tech site Venturebeat, citing anonymous sources, says doctors are too overwhelmed and weary to evaluate how many steps you took this weekend.

Biogen twice-monthly MS drug approved

Biogen twice-monthly MS drug approved

Plegridy is the only pegylated beta-interferon drug approved for relapsing multiple sclerosis.

FDA wants more info on Acura pain drug

FDA wants more info on Acura pain drug

FDA feedback will influence a new clinical trial design, but the regulator's recent reaction was a bit of a surprise.

Five things for pharma marketers to know: Monday, August 18

Five things for pharma marketers to know: Monday, August 18

Roche is rumored to be stalking a Chugai acquisition, Pfizer has hit its palbociclib filing deadline and Supernus scored a Fast Track designation for its experimental ADHD drug.

Five things for pharma marketers to know: Friday, August 15

Five things for pharma marketers to know: Friday, August 15

UK drug-cost watchdog backs Sovaldi, Achillion touts HCV interim results, Avastin's latest cancer indication, Ebola outbreak worsens, COPD drug gets panel nod, and study links quick reviews and black-box warnings.

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.

Endorsement could boost Pfizer vax

Endorsement could boost Pfizer vax

It could also eat into Merck's Pneumovax sales.

InterMune joins M&A fray

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

Employers like "skinny" health plans

These healthcare plans allow employees and employers to avoid ACA penalties but provide little coverage.

FDA tackles women's sexual health

The regulator and patients will chat for two days in October.

Five things for pharma marketers to know: Thursday, August 14

Five things for pharma marketers to know: Thursday, August 14

Merck insomnia aid nabs FDA approval, AZ's severe asthma drug advances to Phase III, Specialty med costs expected to comprise more and more Medicare Part D spending.

AbbVie makes inroads in orphan drugs

AbbVie makes inroads in orphan drugs

Not long after acquiring Shire to add to its orphan-drug portfolio, the drugmaker scored an orphan designation from both FDA and EMA last week.

US diabetes risk jumps to 40%

US diabetes risk jumps to 40%

African-American women had the highest risk of being diagnosed with diabetes—55%. Hispanic men and women were close behind, carrying a 50% risk of being diagnosed with diabetes.

Healthy-habit trackers have short-lived appeal

A study indicates consumers stop using them at the six-month mark.

Prosena gets nonprofit boost

CureDuchenne is giving biotech Prosena $7 million to help its Duchenne Muscular Dystrophy treatment move along.

Colorectal cancer test is FDA moment of sorts

Cologuard was the first approved fecal-based screening test for the disease, and it was also the first product the FDA and CMS approved on the very same day through the so-called Parallel Review program.

Five things for pharma marketers to know: Wednesday, August 13

Five things for pharma marketers to know: Wednesday, August 13

Robin Williams's suicide highlights a trend among the Boomer generation, and governments resurrect a little-used strategy to contain Ebola.

Pharma vet Whitaker takes the helm at Synta

Pharma vet Whitaker takes the helm at Synta

The Sanofi and GSK marketing virtuoso has taken over as CEO and president at Synta Pharmaceuticals.

Boehringer to cut costs by 15%

Layoffs are reported to be in the offing.

GAO tallies cost-effective interventions

GAO tallies cost-effective interventions

Half-measures, like diabetes educational materials without a part B, fared poorly.

FDA clocks record number of recalls

The regulator has already issued more recalls in the first half of 2014 than it has over the past nine years.

Generic Viagra floods Brazil

The generic ED pills sell for five cents less than Pfizer's branded blue pill, but the undercutting is a bit deeper.

India establishes inspection guidelines

The new rules are expected to do away with the haphazard nature of facility inspections.

Five things for pharma marketers to know: Tuesday, August 12

Five things for pharma marketers to know: Tuesday, August 12

The World Health Organization rules on untested Ebola drugs, while Mapp Biopharma has already run out of its experimental antibody.

Monday Moves 8-11

Hires and promotions for manufacturers and agencies

One giant leap for MannKind: Sanofi to market Afrezza

One giant leap for MannKind: Sanofi to market Afrezza

After weeks of speculation as to whether MannKind would find a marketing partner for its inhalable insulin, the drugmaker said today that Sanofi would acquire global licensing rights to the drug for $925 million.

Scotland's NICE dislikes GSK's Anoro

The Scottish Medicines Consortium gave a thumb's down to GSK's drug and a Boehringer COPD drug.

EU mulls new Prevnar 13 indication

A greenlight could garner Pfizer $1B in sales.

Investors want end to biosim trash talk

A group of investors has drawn up a list of business principles which includes not disparaging biosimilars as being inferior to branded biologics.

Roche seeks new Lucentis indication

Roche seeks new Lucentis indication

The company is seeking a diabetic retinopathy indication.

Britain's NICE sidelines Kadcyla

Britain's NICE sidelines Kadcyla

Britain's National Institute for Health and Care Excellence has followed through on its Kadcyla objections and has said Roche's breast cancer drug will remain off the National Health Services formulary because it is too expensive.

Pfizer settles off-label Rapamune case for $35M

Pfizer settles off-label Rapamune case for $35M

The drugmaker will dole out $35 million in a deal with 41 state attorneys general after a New York County Supreme Court judge said Wyeth allegedly promoted the immuno-suppressive drug improperly.

Daiichi increases efforts to break into opioid market

Daiichi increases efforts to break into opioid market

The drugmaker is collaborating with Charleston Laboratories in the development and commercialization of hydrocodone products. The deal means Daiichi Sankyo now has two pipeline opiates.

FDA grants Fast Track to Baxter JAK inhibitor

The experimental drug is being reviewed for patients with intermediate or high-risk myelofibrosis.

Lawmakers want FDA to boot phthalates

Three House democrats are asking the FDA to get the chemical out of US drugs ASAP.

Site has doctors bid for business

Medibid users auction up care in exchange for a low price.

Zohydro to get marketing overhaul

Zohydro to get marketing overhaul

The painkiller's marketer will look to partner with another manufacturer to better target primary care physicians, and will also reexamine its sales territories.

Bayer's Xofigo carves out niche

Bayer's Xofigo carves out niche

Approved in May 2013, the cancer drug earned $57 million in the second quarter, and the firm expects it will hit annual sales of $1.31 billion.

FYI: FDA habla español

The FDA issued a Warning Letter over unapproved drug claims published in Spanish.

WellPoint tests prices, patients

Health insurer WellPoint found patients chose lower-priced MRIs when shown how much locations charged for the very same procedure, but the motivation is murky.

Walgreen keeps US tax status

The Illinois company says it is keeping the US as its home base, which means no inversion benefit.

Lilly and BI's Jardiance could shake up SGLT-2 market

Lilly and BI's Jardiance could shake up SGLT-2 market

Better late than never: Although Lilly and BI's Jardiance is the third SGLT-2 inhibitor to hit the U.S. market this year, it may also be the most successful.

Roche buys Santaris

Roche buys Santaris

The $250 million cash deal includes an additional $200 million in milestone payments.

Senators ask FDA for biosimliar naming rules

Soonish would be good, since a Novartis subsidiary filed a biosimilar with the FDA last month.

Incyte seeks broader Jakafi label

The drugmaker is asking the FDA to approve the drug for polycythemia vera patients.

Acthar marketing drives prescriptions and anger

The decades-old drug is winning prescriptions through marketing, but has a free-pass when it comes to clinical trial data.

Monday Moves—August 4, 2014

The latest additions and promotions from the industry.

Open Payments website 'temporarily' taken offline

The pharma payment verification site has been temporarily shut down by CMS due to incorrect information, ProPublica reported today.

Express Scripts drops Zohydro, brings back Advair

The PBM dropped 25 more drugs from its formulary.

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.

Belviq scripts jump on DTC, rep push

Belviq scripts jump on DTC, rep push

Arena's recent quarter shows weight-loss drug Belviq is on the rise. It follows a DTC push and the recent addition of reps by co-marketer Eisai.

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.

HHS shows how diabetes adds up

HHS shows how diabetes adds up

A 2005-to-2010 survey shows diabetics 65-and-up juggle at least four co-morbid conditions and five medications for them.

Novartis apologizes for slow reporting

Novartis is apologizing to Japan after the Ministry of Health, Labor and Welfare said the company had dragged its feet reporting adverse events for two of its cancer drugs.

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.

Healthcare.gov price rises

The cost of fixing healthcare.gov is hovering at around $1 billion, up from the $677-million figure quoted in December

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.

Cancer PSA features scientists

Stand Up To Cancer is kicking off a PSA that features Grammy-winner Jennifer Hudson and a Genentech scientist.

Lawmakers eye pricing

The Senate Judiciary Committee's antitrust panel is looking into how three major pharmaceutical manufacturers decided to set minimum prices for their contact lenses.

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.

Doctors want to know how CMS plans to display Sunshine payment data

Doctors want to know how CMS plans to display Sunshine payment data

Physician and industry trade groups are asking CMS to explain how context will be provided to the general public around the dollar sums drugmakers ascribe to doctors for things like meals, travel, gifts, consulting and research

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.

AstraZeneca takes on pediatricians

The American Academy of Pediatricians says an AstraZeneca drug for preemies should be used less often, and the drugmaker is fighting back with an ad campaign that says the new guidelines put too many at risk.

UK generic use soared in 2013

Generics made up almost 75% of prescriptions in the United Kingdom last year.

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?

In sunny world of LASIK marketers, a dark underbelly

In sunny world of LASIK marketers, a dark underbelly

Last week, the former FDA branch chief who originally approved LASIK machines asked FDA to reconsider its denial last month of his petition to ban these devices.

Imbruvica lassoes CLL indication

The FDA slapped a Breakthrough Therapy label on the CLL indication pursuit in February.

FDA asks social media "how'm I doin?"

The FDA's Center for Drug Evaluation and Research's Office of Communications wants a system that will help assess its messaging reach across the interwebs and its many forums.

Reckitt Benckiser wants out of pharma

The company plans to spin off its pharmaceutical unit.

AZ seeks blood test to ID potential patients

AstraZeneca's hope is that the blood test could replace tissue samples and be used to identify patients who could benefit from its lung drugs.

Six new Parkinson's factors found

A National Institutes of Health-funded study of over 18,000 patients has identified six new genetic risk factors associated with Parkinson's Disease.

Bayer's Nexavar disappoints in breast cancer

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

Researchers hit links for charity

The PMR Charities Golf Classic teed up more than $20,000 for St. Jude Children's Research Hospital.

BMS Q2 sales slip, Eliquis, Yervoy soar

BMS Q2 sales slip, Eliquis, Yervoy soar

The company attributed part of the Eliquis boost to the BMS-Pfizer DTC and education efforts.

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.

FDA to review Neupogen biosimilar

Novartis subsidiary Sandoz announced Thursday that the FDA has agreed to review its filgrastim biosimilar which is already approved in 40 countries.

FDA approves a new painkiller

Targiniq ER combines the prescription opioid oxycodone and naloxone, which is often used to treat overdoses.

Docs not fans of Valeant-Allergan mix

The Wall Street Journal reports that 44% of dermatologists and plastic surgeons polled in a Sanford Bernstein survey said they would consider Botox alternatives if Allergan becomes a Valeant subsidiary.

Pharma failures get second life

AstraZeneca, GlaxoSmithKline, Takeda, Pfizer and Eli Lilly are among seven drugmakers making their discarded molecules available in what amounts to a molecule library.

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.

Payment database confounds doctors

ProPublica reports that doctors are struggling with a time-intensive registration process and are getting an error message that CMS says is not an error message.

Gilead's idelalisib hat trick

The FDA greenlighted the drug for three cancers.

Shire expands rare disease reach

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

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