Regeneron's Eylea scores Breakthrough label

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

NY sues over Forest Alzheimer's medication

NY's attorney general alleges that a formulation switch is an attempt to create monopoly.

AbbVie ceded generic Tricor to protect AndroGel: FTC suit

AbbVie ceded generic Tricor to protect AndroGel: FTC suit

The FTC is suing AbbVie and two other firms in a pay-for-delay case that could have wider implications for pharma

FDA sanctions don't kill a business

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

FDA lifts OncoMed partial hold

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

GSK Ellipta franchise expands

GSK Ellipta franchise expands

The FDA has approved Arnuity Ellipta for asthma.

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.'"

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.

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: 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.

FDA tackles women's sexual health

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

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.

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.

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.

India establishes inspection guidelines

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

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.

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.

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.

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.

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.

FDA and off-label uses: a balancing act

FDA and off-label uses: a balancing act

FDA's current re-examination of its off-label promotion policies in light of the First Amendment is a delicate balancing act between its rock-solid traditional enforcement posture and a diverse new electronic communications environment.

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

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.

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

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.

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.

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.

FDA gets treatment guidance from patient advocates

FDA gets treatment guidance from patient advocates

Parent Project Muscular Dystrophy (PPMD) and allied stakeholders recently gave FDA the first patient advocacy-initiated guidance for a rare disease to help accelerate development and review of potential therapies for Duchenne muscular dystrophy.

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.

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.

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.

BMS readies nivolumab for melanoma filing

BMS readies nivolumab for melanoma filing

Bristol-Myers Squibb is moving forward with its FDA filing of PD-1 Opdivo (formerly known as nivolumab) for patients with advanced melanoma who have been previously treated with the BMS drug Yervoy.

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.

EU fines six for pay-for-delay

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

"Likes" put Zarbee's in FDA crosshairs

"Likes" put Zarbee's in FDA crosshairs

The FDA says the OTC remedy maker's online behavior—including Liking customer Facebook posts—has put the company's drugs in unapproved drug territory.

OPDP slaps Gilead with Untitled Letter

OPDP slaps Gilead with Untitled Letter

The drugmaker received a notice from the advertising watchdog over promotion of hep. B treatment Viread in a sponsored link on Google AdWords.

Purdue pain drug gets priority status

Purdue pain drug gets priority status

Purdue Pharma expects the FDA to vote yea or nay on the drug by October.

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.

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.

CMS plans to end CME Sunshine exemption

CMS plans to end CME Sunshine exemption

In what amounts to a sudden about face, CMS wants to delete the Sunshine rule's exclusion for continuing medical education.

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.

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.

BI's Pradaxa antidote gets Breakthrough label

FDA says it will fast track the blood-thinner antidote, designed to thwart runaway bleeding.

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.

FDA Guidance expands environmental perspective

The regulator is issuing draft guidance to address gene therapies.

FDA adds to "low-T" drugs' warning label

FDA adds to "low-T" drugs' warning label

Four months after announcing a review of low-testosterone treatments for risk of heart attack and stroke, the regulator expanded the classes' warning label to include a general risk of blood clots.

FDA Twitter guidance greeted with caution

FDA Twitter guidance greeted with caution

Guidance on promoting products in 140 characters and correcting misinformation serves as a guarded green light, says one observer.

PhRMA uneasy about "right-to-try" laws

Colorado's version of the FDA's compassionate use rule does not sit well with lobbying group Pharmaceutical Research and Manufacturers of America.

Lilly, BI resubmit diabetes medication

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

FDA releases new draft social media guidance

FDA issued two guidance documents today for industry and its representatives to communicate online about prescription drugs and devices.

HealthKit won't tangle with the FDA

Recent FDA guidelines for health-tracking apps mean Apple's HealthKit, and similar apps, won't have to jump regulatory hurdles before going live.

FDA labels AbbVie hep C drug Breakthrough

The all-oral genotype 1 medication got the Breakthrough Therapy designation Friday.

OPDP says phentermine site thin on details

OPDP says phentermine site thin on details

The bad-ad watchdog says the promotional website for the weight-loss medication Suprenza leaves out too much information.

FDA pauses Orexigen drug approval

FDA pauses Orexigen drug approval

The regulator wants more time to discuss post-marketing requirements.

Medicare to cover some hep. C screening

Patients have to be high-risk or Baby Boomers for coverage.

Genentech cancer med nabs Breakthrough status

The FDA granted the label for Genentech's experimental metastatic urothelial bladder cancer treatment.

CMS: docs can sign up for Sunshine peek

CMS: docs can sign up for Sunshine peek

Will docs line up to glimpse their payment data—and get a chance to correct mistakes—or will low awareness overshadow the latest milestone in the law's roll-out?

Italy fines Roche and Novartis

The government's anti-trust agency said the drug companies colluded to push doctors toward pricier Lucentis over Avastin.

Boehringer settles Pradaxa suits

The company is settling around 4,000 cases for around $162,500 apiece.

Fraud office looks at GSK

The company announced Tuesday that the UK fraud agency is giving the company a closer look.

FDA examines DTC close up

FDA examines DTC close up

The regulator's latest study will use eye-tracking tools.

FDA invests in clinical trial data

The regulator is allocating almost $38 million to improve data-guided decision-making.

CA counties sue makers of painkillers

Orange and Santa Clara counties are suing painkiller makers like Purdue and Endo, a suit akin to deceptive ad cases launched against the tobacco industry.

China continues industry probe

Roche says reps from China's antitrust agency visited one of its sites.

Sun's FDA Warning Letter

Sun's FDA Warning Letter

The FDA's seven-page letter outlines some of the problems the regulator has with one specific Sun site.

OPDP takes on sales aid for alcohol drug

OPDP takes on sales aid for alcohol drug

The advertising watchdog gave drugmaker Alvogen 15 days to make amends.

Clinical trial nabs SEC attention

The Securities and Exchange Commission alleges that two doctors illegally exploited their clinical trial affiliation for financial gain.

FDA seeks math of similarity

A three-year, $1 million project seeks an equation for generics and biosimilars.

FDA says no to Novartis heart drug

FDA says no to Novartis heart drug

Novartis says the FDA wants more serelaxin efficacy data.

BMS, AbbVie land Breakthrough label

The FDA granted Breakthrough Therapy status to the duo's multiple myeloma treatment.

FDA standing by its Zohydro approval

FDA standing by its Zohydro approval

The regulator defends its approval decision in a web post.

FDA OKs Merck clot drug

Zontivity (vorapaxar) was approved for patients who have already suffered a heart attack or have arterial blockages in the legs.

Xtandi seeks first-line status

The FDA has granted priority review status for the expanded-indication review.

FDA to review generic blood-pressure med

Prompted by thousands of adverse events, the agency is said to be undertaking an extensive review of generic copies of Toprol XL.

Janssen submits HCV combo to FDA

The drugmaker sent Olysio + Sovaldi to regulators for an additional indication in HCV patients with liver scarring.

FDA nixes use of aspirin for primary prevention

FDA warned consumers against using aspirin for primary prevention, following its denial of Bayer's request to allow marketing of aspirin for that use.

Heart pill approval a much-needed win for AZ

Epanova—a drug meant for patients with a high triglyceride count—won approval from FDA today, a small but symbolic win for AZ as it seeks to fend off a takeover attempt by Pfizer.

Olympus pill camera approved

The trackable device offers a 160-degree view of a patient's insides.

FDA panel shoots down OTC Singulair

FDA panel shoots down OTC Singulair

Merck's ex-blockbuster allergy drug, Singulair, received a thumbs-down from an FDA advisory panel asked to consider an OTC switch.

Industry resists FDA power grab on social media

Industry resists FDA power grab on social media

The response period may have ended in mid-April, but some of the harshest criticisms of FDA's social media draft guidance weren't posted until the end of the month.

New painkillers stalk Zohydro

New painkillers stalk Zohydro

Two drugmakers, Purdue Pharma and Teva, have abuse-deterrent hydrocodone medications either under FDA review or in late-stage testing.

Latest Breakthrough nod goes to Novartis

The FDA announced Tuesday its approval of lung cancer drug Zykadia for patients with metastatic ALK-positive non-small cell lung cancer.

Pharma pumps up lobbying spend

Roll Call finds some significant increases in lobbying spend between Q4 and Q1.

Panel votes against painkiller

Panel chair Randall Flick said QRxPharma "had not provided sufficient evidence to support a claim that Moxduo is safer than morphine or oxycodone."

Bayer drug gets orphan label

Bayer drug gets orphan label

The FDA designation is for an experimental, inhaled form of ciprofloxacin intended to treat a rare lung condition.

Boehringer drug lands US, EU orphan tag

Boehringer drug lands US, EU orphan tag

The experimental Breakthrough Therapy treatment is for acute myeloid leukemia.

Sunshine data highlights major billers

Facts tucked among the 9.2 million lines of data: 2% of doctors account for around 25% of Medicare billing.

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