The FDA has approved Arnuity Ellipta for asthma.
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.
GlaxoSmithKline, Actelion, Sanofi and Roche are said to be among a host of suitors.
Layoffs are reported to be in the offing.
Blood-cancer drug Kyprolis outperformed standard treatment in a late-stage trial testing the drug in patients with multiple myeloma, said Amgen.
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.
The meningitis and encephalitis medications earned a combined $300 million last year.
AstraZeneca has made an $875-million move to beef up its respiratory pipeline by making Almirall's lineup its own.
The majority of the layoffs will be in the US.
Patent losses and lost co-promotion agreements put a dent in sales.
The company refutes a Financial Times rumor that one was happening soonish.
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?
The drug did not hit its Phase III primary target of improving progression-free survival.
Disclosed in its earnings report yesterday, Gilead may have a card up its sleeve to counter Merck's experimental hep. C combo regimen.
Biogen Idec is seeing strong sales for blockbuster MS drug Tecfidera, especially overseas where it's beginning to catch fire this summer.
A $225-million deal with US biotech ArmaGen gives Shire worldwide commercialization rights to an experimental enzyme replacement therapy.
Executives urge analysts to focus on the company's long-term potential.
CEO Severin Schwan tells Reuters that the Swiss firm will be looking for small acquisitions and partnerships.
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.
The deal includes a $1.6-billion fee if AbbVie tries to walk away.
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.
Less-frequent dosing and competitive pricing could spur a shift in market share among products that treat the hereditary blood disorder.
Hepatitis C medication Olysio was a star, but the company cautions competition is coming.
The FDA granted Priority Review for consideration of Avastin for some cervical-cancer patients.
An advocacy group alleges that Shire's decision to ignore the US Fabry disease market was the result of a backroom deal with Sanofi.
Shire and AbbVie's courtship has entered round five. A deal would offer AbbVie tax relief, and possibly make it an acquisition target.
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.
In the latest chapter in the Sovaldi pricing saga, Senators Ron Wyden and Charles Grassley urge Gilead to clarify Sovaldi sticker shock.
Allergan will implement company-wide cost-cutting maneuvers, Bloomberg reports, to keep Valeant at bay.
Two weeks after its $46-billion bid was shot down, AbbVie has revised its offer in hopes of opening up negotiations with Shire.
The companies will develop Lilly's glucokinase activator LY2608204.
It's the generics maker's second recall of 2014.
Zogenix is working on a less easily abused formulation of its controversial prescription painkiller.
French lawmakers have the chance to vote for off-label use of Avastin, potentially eating into the turf of higher-priced Lucentis.
Boehringer Ingelheim's experimental idiopathic pulmonary fibrosis treatment nintedanib is also an orphan drug.
The Indian Pharmaceutical Alliance makes a bid for legislators' attention.
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.
The FDA approved the inhaled insulin last week.
Novartis no longer has a lock on the Diovan market: the FDA approved Ranbaxy's generic, which will be made in the US.
Pennsylvania drugmaker Auxilium will merge with Vancouver-based biotech QLT to lower its corporate tax rate.
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.
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.
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.
Dublin-based Shire is urging shareholders to back independence and ignore AbbVie's $46.4 billion bid.
BI says there is no unmet need for faldaprevir.
The companies resubmitted SGLT2 inihibitor empagliflozen for FDA review. The EC approved the drug in May.
The drugmaker is pulling its US marketing application for the anemia drug.
The deal makes Medtronic the most recent company to seek out lower tax rates.
CFO Frank D'Amelio told an investors conference AstraZeneca wanted more money.
CEO David Pyott told Modern Healthcare that acquisition fallout would have probably included a pinched R&D budget and higher product prices.
August 15 is John Johnson's last day as president and CEO.
Merck will test if a pieced-together combo of Idenix's nucleotide inhibitor and its own Breakthrough Therapy regimen can take on the competitive HCV landscape.
The company says the re-lo is for personal reasons. The move will put him in close proximity to Genzyme, as well as other members of the French firm's executive committee.
The company has created three new departments.
The company is buying Genia Technologies for $125 million.
In addition to raising its bid for Allergan, Valeant is lobbying for a shareholder meeting to oust six board members.
The post-Chapter 11 pharmaceutical company unveiled its new name Thursday.
The government's anti-trust agency said the drug companies colluded to push doctors toward pricier Lucentis over Avastin.
The new offer is $49.4 billion.
The drugmaker has paired up with Incyte and CytomyX in two separate deals.
Pfizer announced Monday that it will no longer pursue AstraZeneca, but industry watchers note it may not really be over.
Saeed Motahari, formerly AbbVie's VP of US sales and marketing, specialty brands, is Purdue Pharma's new SVP, chief commercial officer—a new position.
Roche says reps from China's antitrust agency visited one of its sites.
Pfizer still has wiggle room to raise its offer, and some major AstraZeneca shareholders say the company should reconsider staying independent.
The FDA's approval of Takeda's Entyvio puts the drugmaker in the ulcerative colititis and Crohn's mix of prescription treatments.
The company is investing $135 million at two sites in Basel.
AstraZeneca said Pfizer's latest bid for the British drugmaker was too low.
The LLC is adding a 30,000-square-foot operation in South San Francisco.
GlaxoSmithKline says it is cooperating with Chinese authorities.
Santen Pharmaceutical is buying limited rights to Merck's eye portfolio for $600 million and milestone payments.
Pfizer and AstraZeneca present their cases for and against a possible merger to UK lawmakers this week.
Reports indicate Allergan's reported attempt to lure Sanofi and J&J into an partnership have failed, and that the Botox manufacturer has told Valeant to keep its takeover offer to itself.
Eisai announced it was adding sales reps to promote its drug Belviq, while Vivus, maker of Qsymia, fights off a generic marketing application by Actavis.
Analyst reaction to this week's quarterly news reflected a need to woo investors, adding to some negative carryover from the previous year.
Drug quality problems and shortages are behind the shift that will affect antibiotics, painkillers and vitamins.
An EY report finds that pharma is not only failing to give payers the right type of drug data, but that industry has a lot of trust-building to do before they will accept it.
The firm laid out reasons for why it should remain independent of Pfizer, but analysts say projected earnings are a bit too optimistic and could be a ploy to up the offer.
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.
The $14.2-billion deal is expected to close in the second half of this year.
A survey by investment firm Jefferies found that the temporary 2013 suspension had a minimal impact on how doctors perceive the drug.
PMLive reports Reckitt has abandoned its bid for Merck's OTC business
CEO Ian Read told investors Monday that an AZ merger would benefit Astra shareholders and add oomph to its marketing potential. Another exec said he could "envision" filing palbociclib this year, but made no promises.
According to a source quoted by Bloomberg, the company has made an offer of $106 billion to acquire AstraZeneca.
An analysis by Bloomberg today shows why drug pricing "keeps defying the law of gravity."
US sales fell 10%, and corruption allegations in China ate into emerging-market sales.
Insider-trading allegations have temporarily stopped the merger.
Bloomberg says the Botox manufacturer has reached out to Sanofi and Johnson & Johnson.
The FDA announced Tuesday its approval of lung cancer drug Zykadia for patients with metastatic ALK-positive non-small cell lung cancer.
Sales of its big diabetes franchise rose 3% vs. the same period last year, while drops in Singulair and Nasonex revenue marked the quarter. The company is slated to reveal pipeline progress next week.
Sanofi's CEO signaled an aversion to a major merger, as he announced the firm's light first-quarter revenue.
Sales slipped 1% for the quarter, but the drugmaker couched the financials with news from its much-watched effort in immuno-oncology: that it will wrap its nivolumab filing by the end of this year.
Pfizer disclosed a renewed push for British rival AstraZeneca, after a $100-billion cash-and-stock offer was rebuffed. A final deal would give the New York drugmaker a presence in immuno-oncology.
US sales fell 34% during the quarter, largely due to lower demand and lower prices for off-patent Cymbalta and Evista.
The company expects to file an sNDA for plaque psoriasis next year.
Sales rose 5% compared to the same period last year.
Sovaldi's debut has been marked by plenty of criticism from payers and lawmakers, but the hep. C drug's launch, now confirmed to be the fastest of all time, has also reaped blockbuster sales for Gilead.
Panel chair Randall Flick said QRxPharma "had not provided sufficient evidence to support a claim that Moxduo is safer than morphine or oxycodone."
The FDA designation is for an experimental, inhaled form of ciprofloxacin intended to treat a rare lung condition.
The deal would bring Allergan's Botox and Juvederm under the same roof as Restylane.
The company said it plans to file its rare-disease drug with the FDA later this year, for a 2015 review.