FDA rejects Heron, Nabriva drug applications, citing manufacturing concerns

Both biotechs expected approval of their respective pain and anti-infective drugs, but wound up with disappointment and delays.

By Andrew Dunn • May 2, 2019

CMS reopens coverage determination on next-gen sequencing for cancer patients

The agency responded to pressure from healthcare organizations in reopening the coverage determination for next-generation sequencing.

By Susan Kelly • April 30, 2019

Alexion, AstraZeneca secure backing of EMA panel for key drugs

The CHMP's recommendation for Ultomiris aids Alexion's Soliris switching strategy, while AstraZeneca's Lynparza aims to move up another treatment line.

By Jonathan Gardner • April 29, 2019

Praluent scores heart label, matching Amgen's rival Repatha

The cholesterol drug from Sanofi and Regeneron is now approved for prevention of cardiovascular events like heart attack or stroke.

By Ned Pagliarulo • April 29, 2019

Roche's takeout of Spark not working like a Swiss watch

Antitrust review drags on, forcing the two parties to withdraw and refile paperwork and extend the tender offer by another month.

By Jonathan Gardner • April 26, 2019

Lilly to withdraw FDA-approved cancer drug after clinical failure

Lartruvo showed no survival benefit in Phase 3 study results disclosed in January, leading Lilly to suspend promotion and pull the drug from market. 

By Andrew Dunn • April 25, 2019

Medicare proposes raising CAR-T pay, but reimbursement solution years away

As new technologies nip at CAR-T's heels, CMS could take three years to gin up a separate reimbursement category for Novartis' Kymriah and Gilead's Yescarta.

By Jonathan Gardner • April 24, 2019

AbbVie's Skyrizi wins its first FDA approval, springing blockbuster ambitions

Although Skyrizi already faces competition from multiple major pharmas, AbbVie predicts $5 billion in sales for the drug by 2023.

By Andrew Dunn • April 24, 2019

Keytruda approved in kidney cancer, challenging Bristol-Myers

An early OK for Merck's pairing of Keytruda and Inlyta in frontline renal cell carcinoma adds a powerful competitor to a market important for Bristol-Myers.

By Ned Pagliarulo • April 22, 2019

Teva wins generic Narcan approval as FDA mulls bolder actions

The naloxone market could get a boost if the FDA decides to recommend co-prescribing the reversal agent with opioids — a step now under consideration. 

By Andrew Dunn • April 22, 2019

Keytruda widens reach in lung cancer with new approval

Merck's flagship cancer drug is now cleared for use in previously untreated patients with Stage 3 non-small lung cancer not suited for surgery or chemoradiation.

By Suzanne Elvidge • April 12, 2019

J&J wins FDA OK for first targeted therapy in bladder cancer

Balversa is also the first drug cleared by the regulator that targets mutations in a gene called FGFR. 

By Ned Pagliarulo • April 12, 2019

'Female Viagra' keeps alcohol black box warning amid FDA dispute with Sprout

The regulator was dissatisfied with the design of a post-marketing study that tested the effects of drinking alcohol while on the Addyi pill.

By Andrew Dunn • April 12, 2019

FDA clears 40 impurity-free ARBs to ease antihypertensive shortages

Agency officials stressed the risk to patients is small and urged those on the heart meds to consult a doctor before discontinuing them.

By Suzanne Elvidge • April 11, 2019

Amgen wins FDA approval for osteoporosis drug Evenity

It's a reversal from two years ago, when regulators rejected the bone-building therapy, which will carry a boxed warning for heart risks.

By Kristin Jensen • April 10, 2019

Indivior draws criminal indictment for opioid marketing practices

The federal government is seeking a $3 billion judgment and forfeiture of all assets, raising concerns about whether the company can survive.

By Jonathan Gardner • April 10, 2019

Zogenix flummoxes investors as FDA refuses to review epilepsy drug

"This requirement is definitely unexpected for us," CEO Stephen Farr said Monday afternoon, referring to the FDA's issues with preclinical data missing from Zogenix's drug application. 

By Andrew Dunn • April 9, 2019

Hospitals, payers decry HHS proposal to change safe harbor for drug rebates

The comments come as PBM chiefs from UnitedHealthcare's Optum, Cigna's Express Scripts and CVS Caremark testify before Senate Finance Tuesday. 

By Les Masterson • April 9, 2019

FDA warns Virginia lab over illegal marketing of genetic test

The sanction of Inova Genomics Laboratory comes as Congress considers granting the FDA more authority to regulate laboratory developed tests.  

By David Lim • April 5, 2019

Copay assistance snares 3 drug companies in Medicare kickback charges

Alexion, Jazz and Lundbeck will pay $123 million to settle charges they used patient assistance foundations to boost prescriptions.

By Jonathan Gardner • April 5, 2019

Pfizer wins expanded Ibrance approval using real world data

Relying on EHRs and real-world use of the cancer drug, the FDA broadened Ibrance's label to include men with certain advanced breast cancers. 

By Ned Pagliarulo • April 5, 2019

What to look for after Zolgensma's launch

An ICER report provides clues on how payers will hedge their reimbursement bets for a likely million-dollar neuromuscular-disease treatment.

By Jonathan Gardner • April 4, 2019

FDA warns of potential violations at 21 stem cell clinics, manufacturers

Agency leaders said some stem cell companies are deceiving patients by "flouting the statutes and our regulations" and "falsely promoting their benefits."

By Kristin Jensen • April 4, 2019

Allergan eye drug fails to impress on safety, upping pressure ahead of key meeting

Analysts were skeptical of the new data on abicipar, giving investors new reasons to question Allergan's pipeline before a May 1 annual meeting.

By Andrew Dunn • April 3, 2019

Sandoz resubmission puts Amgen's Neulasta at further risk of competition

Nearly three years after the FDA rejected the Novartis unit's biosimilar application, the company is trying again.

By Andrew Dunn • April 3, 2019