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.

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.'"

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.

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.

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.

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.

Boehringer to cut costs by 15%

Layoffs are reported to be in the offing.

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.

Monday Moves 8-11

Hires and promotions for manufacturers and agencies

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.

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.

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.

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.

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 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.

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.

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.

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.

Avastin pockets another Priority Review label

It's the second for this cancer drug in two weeks.

Court invalidates some healthcare subsidies

The lawsuit has been wending its way through the courts for a while, and, although it is being deliberated in several other venues, the decision is part of a legal dispute that puts patients in the 36 states offering federal exchanges in limbo.

FDA generic division overhaul kicks in

The Food and Drug Administration has been intent on elevating and reorganizing its office of Generic Drugs since 2012.

NIH: HPV test beats Pap for cancer assessment

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

Miss Idaho shows off diabetes pump

NPR reports that the move has made Sierra Sandison a type 1 diabetes hero and that users have given the Facebook photo over 4,000 "likes."

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.

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.

Leading AIDS researcher aboard downed flight MH17

Dr. Joep Lange was en route to the International AIDS Conference in Melbourne, Australia.

Digital sage Richman returns to healthcare

He started the Dose of Digital blog in 2008, then left healthcare. Now, after more than two years away, Jonathan Richman says he's back in the business.

Haymarket launches psychiatry news, CME site

Haymarket Media launched the site PsychiatryAdvisor.com today.

Treasury urges tax inversion action

Treasury Secretary Jacob Lew is urging lawmakers to prevent companies from "effectively renouncing their citizenship to get out of paying taxes," while also benefitting from the US-funded infrastructure.

Metric system boosts Rx accuracy

Researchers found that patients were more accurate when doling out medication measured in milliliters as opposed to teaspoons or tablespoons.

Vet drugmakers get Warning Letters too

Regulatory Focus reports that the regulator has issued a Warning Letter to AB Science for marketing its canine tumor drug Kinavet for unapproved, off-label uses.

Industry trims support for CME

Industry reined in commercial support for CME in 2013—the sixth consecutive annual decrease—data released today by the ACCME show.

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.

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.

Study links Actos with delayed dementia

German healthcare data from 2004 through 2010 across a data set that included 146,000 patients shows dementia surfaced later among Actos patients.

Committee votes on two health bills today

The House Energy and Commerce Committee is putting two health-related bills to vote Monday. One covers new sunscreen ingredients, the other muscular dystrophy research.

FDA quicker on approval trigger than EU: study

The FDA began its drug review at a median time of 103 days sooner than the EMA. Being first, researchers found, often resulted in quicker approval.

Allergan trims fat to halt takeover

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

Generics trigger wallet shock

Prices for some generics are rising, thanks to limited competition.

Experiment cuts cancer costs, ups drug spend

UnitedHealthcare finds drug costs more than doubled.

EU fines six for pay-for-delay

Servier and Teva have been fined for keeping a generic heart medication off the market.

Lilly, Yabao collaborate on diabetes

The companies will develop Lilly's glucokinase activator LY2608204.

CVS joins West Virginia pseudoephedrine fight

The drugstore chain will no longer sell Sudafed in West Virginia.

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.

Healthcare organization makes big data bigger

Credit card and loyalty program purchases will help Carolinas HealthCare System flag potential patient behavior issues.

Merck stifles ezetimibe criticism

The head of evidence-based medicine at Milan's health authority Alberto Donzelli has pulled down criticism of Merck's cholesterol drug ezetimibe from his website, after the drugmaker sent two cease-and-desist letters.

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.

EC cracks down on fraudulent drugs

The European Commission is rolling out a verified-account tag it hopes will connect Internet users with trustworthy drug sources.

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.

Insurers put in bid for biosimilar naming

Health insurers and pharmacies signed a letter asking the FDA to require biosimilars and branded biologics to share the same name.

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.

Merck rolls out MedEd website in India

The website is a joint effort between Merck and The Lancet.

Email Newsletters