Drugs
FDA has approved an Amgen supplemental BLA for the expanded use of Enbrel (etanercept) to treat pediatric patients (ages 4-17) with chronic moderate-to-severe plaque psoriasis. Approval is based on data from a Phase 3 one-year study and its five-year open-label extension study. “In addition
Drugs
FDA has granted AbbVie an Orphan Drug Designation for veliparib, an oral poly (adenosine diphosphate-ribose) polymerase (PARP) inhibitor, being investigated in combination with chemotherapy or radiation for treating advanced squamous non-small cell lung cancer. The company describes PARP as a naturally-occurring enzyme in the body that repairs
Drugs
FDA has released a guidance on “Clinical Considerations for Investigational Device Exemption (IDEs) for Neurological Devices Targeting Disease Progression and Clinical Outcomes.” The document is intended to assist sponsors interested in submitting an IDE to conduct clinical trials on devices targeting neurological disease progression and clinically meaningful patient centered outcomes.
Drugs
New CDER review documents embedded in a just-released approval package for Sarepta’s controversial Duchenne drug Exondys 51 (eteplirsen) shows how contentious a dispute between director Janet Woodcock and Office of Drug Evaluation 1 director Ellis Unger had become in the final days before Woodcock overrode his decision to
Drugs
Sen. Bernie Sanders (I-VT) and Rep. Elijah Cummings (D-MD) have asked the Justice Department and the Federal Trade Commission to investigate potential collusion among pharmaceutical companies that manufacture diabetes products. “The prices of insulin medications, which are used by about 6 million Americans to treat diabetes, have skyrocketed
Drugs
Lupin says it has resolved GMP deficiencies cited by FDA during an inspection in March at its Goa, India manufacturing plant. The agency issued a nine-item Form-483 related to “inadequacy and adherence to SOPs,” the company said after the inspection. The Goa facility manufactures a range of finished
Drugs
University of Arizona/New York University law school professor Christopher Robertson and Harvard Medical School professor Aaron Kesselheim are urging FDA to stand firm against court decisions on off-label promotion that could lead the agency away from its mission to approve regulated products based solely on scientific evidence. Writing
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Aurinia Pharmaceuticals says it has received positive FDA feedback to plan a single Phase 3 clinical trial for voclosporin and its use in treating lupus nephritis (LN). The encouragement came from the CDER Division of Pulmonary, Allergy and Rheumatology Products during an end-of-Phase 2 meeting, the company says.
Drugs
KemPharm has filed a formal dispute resolution request over a June FDA complete response letter on an NDA for Apadaz (benzhydrocodone and acetaminophen), an investigational abuse-deterrent product candidate for the short-term management of acute pain. The complete response letter was in response to an NDA amendment that the
Drugs
Attorney Peter Hawkes (Lane Powell) says the 9th Circuit Court of Appeals has held that Arena Pharmaceuticals’ actions in informing investors about its weight-loss drug lorcaserin gave rise to a strong inference of scienter (legally, intent or knowledge of wrongdoing) since the company knew of FDA’s concerns about
Drugs
FDA has issued a guidance, Collection of Race and Ethnicity Data in Clinical Trials, with the agency’s expectations for and recommendations on using a standardized approach for collecting and reporting race and ethnicity data in submissions for clinical trials for FDA regulated products conducted in the U.S. and
Drugs
FDA medical reviewers are expressing concern about hepatotoxicity in Cempra’s solithromycin, which goes before the agency’s Antimicrobial Drugs Advisory Committee 11/4 seeking support for an indication to treat community acquired bacterial pneumonia (CABP). A briefing paper released in advance of the meeting says the rates of transaminase
Drugs
Celgene and IBM Watson Health have decided to collaborate to co-develop a new program, IBM Watson for Patient Safety, that aims to enhance pharmacovigilance methods used to collect, assess, monitor, and report adverse drug reactions. The new offering will run on the Watson Health Cloud. “The collaboration will combine
Drugs
FDA says it will be holding a public workshop 5/3/2017 to obtain input from industry and other interested stakeholders on the identification of generic drug regulatory science priorities for FY 2018. The workshop will be held at the FDA White Oak campus, Room 1503A (Great Room), Silver Spring,
Drugs
A 7/20-8/6/15 FDA inspection at Walgreens Home Care (now operating under the name Option Care Enterprises), San Antonio, TX, found serious deficiencies in the firm’s practices for producing sterile drug products that put patients at risk, according to a 10/19 Warning Letter from the
Drugs
Pfizer says it will discontinue its global clinical development program for bococizumab, an investigational proprotein convertase subtilisin kexin type 9 inhibitor (PCSK9i) intended for treating high cholesterol. “The totality of clinical information now available for bococizumab, taken together with the evolving treatment and market landscape for lipid-lowering agents, indicates
Drugs
FDA commissioner Robert Califf says he believes the drug industry “is near the tipping point where companies can use data sources to collect what they need” for regulatory approval, thus reducing the cost of clinical trials. Speaking in an interview at Cardiovascular Research Foundation’s TCT 2016, Califf said he
Drugs
KMR Group says its annual Clinical Trial Cycle Time report shows that the duration of clinical trials associated with large molecule drugs is significantly longer than it is for trials associated with small molecule drugs. The consultants say that even after accounting for disease complexity and study size, large molecule
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FDA has accepted for review an Ariad Pharmaceuticals NDA for brigatinib, an investigational oral anaplastic lymphoma kinase (ALK) inhibitor for use in patients with metastatic ALK-positive (ALK+) non-small cell lung cancer (NSCLC) who have progressed on crizotinib. The agency granted a priority review and set a user fee
Drugs
The Washington Legal Foundation and the National Association of Manufacturers are asking the 3rd Circuit Court of Appeals to overturn a Pennsylvania federal court ruling allowing the state of Louisiana to proceed with “copycat” Flonase litigation after the court approved a class-wide settlement that included Louisiana. In an amicus
Drugs
FDA says that Beijing Taiyang Pharmaceutical Co., Beijing, China, limited and/or refused an FDA inspection on 11/16/15. A 10/19 Warning Letter says the firm’s drugs are adulterated in that they have been manufactured, processed, packed, or held in an establishment where the owner or operator
Drugs
FDA has accepted for priority review a Novartis NDA for LEE011 (ribociclib) as a first-line treatment of postmenopausal women with hormone-receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer in combination with letrozole. The submission is based in data from the