Five things for Pharma Marketers to know: Friday, August 29

Five things for Pharma Marketers to know: Friday, August 29

Takeda closes out a good-news, bad-news kind of week, AstraZeneca adds a new clinical trial for its experimental PD-1, and researchers link a funeral to the Ebola outbreak.

Amgen sends PCSK9 to FDA

Amgen sends PCSK9 to FDA

Evolocumab holds the FDA's first filed biologics license application for the class.

Consultants expect M&A tempo to continue

Consultants expect M&A tempo to continue

PwC anticipates that divestitures will fuel late-2014 deals, but notes that the noise around early deals and the financials don't fully match up.

Apple selfies spur diabetes donations

Jazz apples has launched a Crunch to Contribute campaign to raise money for one of two diabetes associations.

Baxter seeks Cambridge, Mass. HQ

Illinois may be tempted to offer tax incentives for the firm to stay put.

Five things for Pharma Marketers to Know: Thursday, August 28

Five things for Pharma Marketers to Know: Thursday, August 28

Human testing of GSK's Ebola virus starts next week, menopause is a costly healthcare concern, and a small conversation with pharmacists may have a big impact.

Judge blocks FDA bid to allow generic Precedex

Judge blocks FDA bid to allow generic Precedex

The US District Court for Maryland granted Hospira a temporary restraining order (TRO) against FDA, after the agency determined that potential generic competitors of the company's injectable sedation drug Precedex could be approved.

GSK drug gets aplastic anemia indication

GSK drug gets aplastic anemia indication

Promacta was previously indicated for chronic immune thrombocytopenia.

FDA wants Alexion to clean up

FDA inspectors have cited the manufacturer of the rare-disease drug Soliris (eculizumab) for poor manufacturing practices.

Painkiller maker Acura gets NIH grant

The $300,000 grant will go towards an abuse-deterrent technology.

Five things for Pharma Marketers to know: Wednesday, August 27

Five things for Pharma Marketers to know: Wednesday, August 27

Allergan sets a shareholder voting date, Novo describes the types of acquisitions it will consider, and the AstraZeneca-Pfizer talks can now reopen.

Eli Lilly and BI's Jardiance hits shelves

Eli Lilly and BI's Jardiance hits shelves

The new SGLT-2 inhibitor is on shelves less than a month after FDA approval.

Biologics have higher psoriatic arthritis adherence

A study of psoriatic arthritis patients found greater adherence among patients whose initial treatment was a biologic, compared to those who started with a non-biologic treatment.

IRS struggles with device tax

A Treasury report says the IRS is having trouble identifying who owes it money.

PhRMA Urges Court to Reject Off-Label Promotion Case

PhRMA Urges Court to Reject Off-Label Promotion Case

The Pharmaceutical Research and Manufacturers of America (PhRMA) says a California federal court should dismiss a whistleblower's False Claims Act suit against three drug companies on First Amendment grounds

Five things for Pharma Marketers to know: Tuesday, August 26

Five things for Pharma Marketers to know: Tuesday, August 26

Merck and Pfizer pursue new pembrolizumab research, black box warnings are linked to fewer court visits, and the WHO says it needs $430M to fight Ebola.

FDA Cautions Consumers on Ebola Web Promotions

FDA Cautions Consumers on Ebola Web Promotions

FDA says that it is seeing and receiving consumer complaints about products sold online that claim to either prevent the Ebola virus or treat it.

Roche spends $8.3B for lung drug

Roche spends $8.3B for lung drug

Roche has beat out rumored competitors GlaxoSmithKline and Sanofi in a run-off to acquire California biotech InterMune.

White House proposes Hobby Lobby alternative

A proposal by the Obama administration Friday seeks to keep contraception accessible and coverage approval at arm's length for employees of religious non-profits.

Study: move more, eat less, save $500

Diet and exercise can help some type-2 diabetes patients save around $500 in medical expenses every year.

J&J, Vivus patent suit ends

J&J subsidiary Janssen has abandoned its patent lawsuit over the anti-seizure medication topiramate, which is part of Vivus's prescription weight-loss drug Qsymia.

Five things for pharma marketers to know: Monday, August 25

Five things for pharma marketers to know: Monday, August 25

Roche backs away from Chugai but embraces InterMune, Merck rumored on track to score first PD-1 approval, a new Ebola strain may have surfaced and JNJ scoops up experimental anti-TNF.

Monday Moves August 25

Manufacturer and Agency hires and promotions

Five things for pharma marketers to know: Friday, August 22

Five things for pharma marketers to know: Friday, August 22

Two new indications give Eliquis more juice, a new rule is making hydrocodone harder to get and the ALS Ice Bucket Challenge highlights a controversial aspects of drug discovery and development.

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.

Illumina inks deal with J&J, AstraZeneca, Sanofi

The goal is to develop companion diagnostics to match patients with cancer treatments.

Abbott deal highlights inversion inaction

Political furor over the recent spate of tax inversions is having little influence on how the government chooses its partners.

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.

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