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List of Medications Facing Inflation-Linked Rebates Increases

June 12th, 2023|Categories: Featured, Industry News|Tags: , , , , |

The Centers for Medicare and Medicaid Services (CMS) has expanded the list of drugs that will be subject to rebates tied to price increases that exceed the current rate of inflation. The number, which was previously 20, now stands at 43, and includes drugs for leukemia, lymphoma, and asthma from major manufacturers like Seagen, Amgen, and AstraZeneca.

FDA Advisory Committee Votes in Favor of Eisai, Biogen’s Leqembi

June 9th, 2023|Categories: Featured, Industry News|Tags: , , , |

An advisory committee for the US Food and Drug Administration (FDA) voted 6-0 in favor of full approval for Leqembi, Eisai and Biogen’s treatment for Alzheimer's disease. The decision was made based on results from the Clarity AD study, which the committee members believed strongly supported its clinical benefits for patients.

FDA Brief Supports Full Approval for Alzheimer’s Drug Leqembi

June 8th, 2023|Categories: Featured, Industry News|Tags: , , , |

In a newly released brief, the US Food and Drug Administration (FDA) vocalized support for the full approval of Eisai and Biogen’s Alzheimer's drug Leqembi. The brief, which comes before an FDA adcomm this Friday, June 9th, shows that the agency considers the drug’s efficacy well-supported by evidence from a recent study and that the risk of adverse events does not rule out full approval.

The Odds Don’t Favor Merck’s Drug Price Negotiation Lawsuit

June 8th, 2023|Categories: Featured, Industry News|Tags: , , , , |

Merck filed suit against the Centers for Medicare and Medicaid Services (CMS) recently, marking the first pharmaceutical company to do so. However, according to Stephen L. Carter of Bloomberg, the lawsuit may be dead in the water. The reason, he argues, is the basis of the suit, which hinges on the idea that price caps equate to the government seizing private property without fair compensation and that the language of the bill is a violation of the First Amendment.

GSK’s RSV Vaccine Nabs First EU Approval of its Kind

June 7th, 2023|Categories: Featured, Industry News|Tags: , , , , |

Glaxo-Smith Klein (GSK) has received approval by the European Commission for its respiratory syncytial virus (RSV) vaccine Arexvy in adults aged 60 and up. This marks the first EU approval of a vaccine for RSV vaccine. This puts them ahead of Pfizer, whose vaccine Abrysvo has yet to be approved in the EU.

PBM Industry Pushes Back Against Pharma Lobbyists

June 6th, 2023|Categories: Featured, Industry News|Tags: , , , , |

Amid growing scrutiny of pharmacy benefit managers (PBMs) at the public and congressional level, a PBM industry group has launched an ad campaign pointing the blame back at pharma for high drug prices. The group argues that the pharmaceutical industry has spent millions of dollars on advertising and lobbying that places the onus of high drug prices on PBM practices while side skirting their own responsibility for setting list prices.

First Lawsuit Against US Medicare Drug Pricing Negotiations Filed by Merck

June 6th, 2023|Categories: Featured, HEOR Feature, Industry News|Tags: , , , , |

The pharma giant Merck & Co has filed a lawsuit against the US government over upcoming Medicare drug pricing negotiations included in the Inflation Reduction Act passed last year. The company argues that the negotiations would violate their 5th Amendment rights by forcing them to provide drugs at prices lower than market value.

AstraZeneca Looking Toward Early Full Approval for Anticoagulant Reversal Medication

June 5th, 2023|Categories: Featured, Industry News|Tags: , , , , |

Following positive results in a phase IV clinical trial, Astrazeneca is making moves to apply for full approval for its anticoagulant reversal drug Andexxa earlier than expected. Data from the trial, which is being ended early based on outside recommendations, showed that the drug was effective in patients on certain anticoagulants who are experiencing an intracranial hemorrhage.

Inflation Reduction Act R&D Cost Request May Prove Problematic

June 5th, 2023|Categories: Featured, Industry News|Tags: , , , , |

The US Inflation Reduction Act requires drugmakers to justify new drug prices based on the R&D costs needed to develop a therapeutic during drug pricing negotiations. However, this policy may be short-sighted, according to some experts, as it doesn’t account for the lost investments in failed drugs or the overall value provided to patients.

Bristol Myers Squibb’s Heart Medication Camzyos Receives NICE Recommendation

June 5th, 2023|Categories: Featured, Industry News|Tags: , , |

Bristol Myers Squibb (BMS) has received a recommendation for approval from the UK’s National Institute for Health and Care Excellence (NICE) for its heart drug Camzyos (mavacamten). The recommendation covers the use of the drug as a adjunct treatment for symtompatic obstructive hypertrophic cardiomyopathy, a condition of reduced blood flow caused by thickening of certain walls in the heart.

CMS Drug Price Negotiations Complicated by Therapeutic Alternatives Clause

June 5th, 2023|Categories: Featured, Industry News|Tags: , , , , |

As part of the upcoming drug pricing negotiations from the Inflation Reduction Act, drugmakers will need to justify high US drug prices by comparing efficacy and value with therapeutic alternatives. The problem, according to industry leaders, is that the definition of therapeutic alternatives is unclear. Beyond that, these filings have a small max word count, making applications even trickier.

EMA Calls for Novartis’ Sickle Cell Treatment to Lose Market Authorization

June 2nd, 2023|Categories: Featured, Industry News|Tags: , , , , |

Novartis took a hit this week as the European Medicines Agency (EMA) has recommended that its market authorization for Adakveo, a sickle cell medication, be revoked. Although initial data suggested the drug could help reduce pain crises in patients 16 and older, the agency argues that new data showing increased levels of serious side effects do not outweigh the modest treatment effect.

Working with Pharma to Advance NHS Health Equity Efforts

June 2nd, 2023|Categories: Featured, Industry News|Tags: , , , , |

A key priority in the UK’s National Health Service (NHS) Operational Planning Guidance 2023/2024 is improving health outcomes for the poorest 20% of patients in the nation. Partnerships between NHS systems and the pharmaceutical industry represent one way to help address health disparities. Doing so, however, requires understanding the problem at hand and acting precisely.

Pfizer’s RSV Vaccine Gets FDA Approval

June 1st, 2023|Categories: Featured, Industry News|Tags: , , , , |

The US Food and Drug Administration (FDA) has given approval for the use of Pfizer’s respiratory syncytial virus (RSV) vaccine in older adults. The move comes shortly after the agency approved another RSV vaccine from GSK. This sets up a marketplace standoff between the two, competing over a market that’s estimated at $17 billion.

US Congressional Research Service Asks When Pharma Can Challenge Drug Pricing Reform

May 31st, 2023|Categories: Featured, Industry News|Tags: , , , |

The Congressional Research Service (CRS), a nonpartisan public policy research institute, released a report asking for more clarity on when lawsuits over upcoming Medicare drug pricing reform can commence. The report comes as industry groups also seek more transparency on time windows as they prepare their legal challenges in advance.

Eli Lilly Reaches $13.5 Million Settlement in Insulin Pricing Case

May 31st, 2023|Categories: Featured, Industry News|Tags: , , , , |

Eli Lilly has settled a case with patients using insulin, who accused the company and others of artificially inflating prices of the lifesaving drug. Lilly will pay out a total of $13.5 million and will maintain their $35 a month out-of-pocket price cap for four years at minimum. The company, which claims no wrongdoing occurred, will apply this cap to three insulin products, Humalog, Humulin, and Basaglar.

Canadian Health Officials Tried to Hide Evidence Health Minister Stalled Drug Pricing Reform

May 31st, 2023|Categories: Featured, Industry News|Tags: , , , , |

Recently released emails show that Health Canada officials tried to hide a letter from Health Minister Jean-Yves Duclos to the Patented Medicines Prices Review Board (PMPRB), Canada’s independent drug pricing agency, asking them to delay drug pricing reform last year. The letter mirrored the pharma industry’s concerns and led to the reform being postponed.

US FDA Fast Tracks Antithrombotic from BMS and J&J

May 26th, 2023|Categories: Featured, Industry News|Tags: , , , , |

Johnson & Johnson and Bristol Meyer’s Squibb’s (BMS’s) antithrombotic milvexian has been fast tracked by the US Food and Drug Administration for three indications, according to the companies. The drug received the designation for the drug for stroke, atrial fibrillation, and acute coronary syndrome. Fast track designation is often granted for drugs that address medical conditions with limited treatment options.

US FDA Approves Paxlovid for High-Risk Adults

May 26th, 2023|Categories: Featured, Industry News|Tags: , , , |

The US Food and Drug Administration (FDA) approved Pfizer’s Paxlovid for patients at high risk of severe COVID-19 this week. The move is based on a randomized clinical trial that found that unvaccinated patients who had not been infected by COVID-19 before were 86% less likely to be hospitalized if given Paxlovid early in the disease. However, some experts have expressed concern over whether these results will translate to people who are up-to-date on their vaccinations.

India’s NPPA Cuts Off-Patent Drug Ceiling Prices by Half

May 26th, 2023|Categories: Featured, Industry News|Tags: , , , , |

The National Pharmaceutical Pricing Authority (NPPA), India’s drug pricing agency, has announced it will cut the ceiling price of off-patent drugs by half to address profiteering in the pharmaceutical industry. The list of drugs covers much of the country’s National List of Essential Medicines (NLEM). Many pharma companies have lambasted the plan, saying it will negatively impact their profits.

US House Members Call on FDA to Address Chemotherapy Shortages

May 25th, 2023|Categories: Featured, Industry News|Tags: , , , |

A bipartisan group of US House representatives is calling on the Food and Drug Administration (FDA) to address ongoing shortages of key chemotherapy drugs. In a letter written by Debbie Dingell (D-MI) and Tim Wahlberg (R-MI), lawmakers highlight the current shortages of cisplatin and carboplatin and point out they were either caused or exacerbated by a manufacturing hold last year on Intas Pharmaceuticals over quality issues.

FDA’s CDER Looking Towards Quicker Accelerated Approval Withdrawal Approach

May 24th, 2023|Categories: Featured, Industry News|Tags: , , |

The US Food and Drug Omnibus Reform Act (FDORA) empowered the Center for Drug Evaluation and Research (CDER) with the ability to expedite the withdrawal of drugs that were granted accelerated approval if confirmatory trials are not successful. The new process, which has yet to be rolled out, will be covered in a new guidance that will be up for public comment.

Biden Admin Proposes CMS Rule to Make Drug Manufacturing Costs Transparent

May 24th, 2023|Categories: Featured, Industry News|Tags: , , , |

The Biden administration and the Centers for Medicare and Medicaid Services (CMS) have put forward a new rule intended to bolster drug price transparency by highlighting drug manufacturing and transportation costs. This would be performed via a variety of tools, including a drug price verification survey that would be issued when new drugs are priced or existing drugs see price hikes.

Indian Pharma Group Petitions NPPA to Establish Prospective Batch Pricing

May 23rd, 2023|Categories: Featured, Industry News|Tags: , , , |

When India’s National Pharmaceutical Pricing Authority (NPPA) sets ceiling prices for drugs, pharma companies can be fined if even one pharmacist charges higher. As a result, the Indian Drug Manufacturer’s Association (IDMA), should put in place prospective price batching that would apply the new price to the next batch of drugs being released.

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