Search This Blog

Monday, July 13, 2026

Germany pushes through healthcare reform package despite pharma's drug discount resistance

 Even as the effort has met with fierce pushback from drugmakers, trade groups and opposition parties in the country’s own government, German lawmakers late Friday voted to pass health insurance reforms aiming to cut healthcare costs next year, in part by hiking up mandatory rebates that pharmas must pay on branded medicines. 

Still, previous resistance appears to have spared the pharmaceutical industry from at least one negative outcome in the central European nation, which often serves as a proving ground for innovative drug launches in the EU. 

Late Friday, 318 members of Germany’s lower house of parliament, the Bundestag, voted in favor of the financial reform proposal, overcoming 284 ‘no’ votes and 4 abstentions to approve the measure. 

The insurance reform was then blessed by the Bundesrat, the country’s upper parliamentary house, formally clearing the way for measures that will impose higher co-pays for prescription drugs and tighter insurance restrictions for married couples, among other changes, German outlet Deutsche Welle reported late last week. 

Notably for medicines manufacturers, the healthcare package has lifted the fixed markdown drugmakers must pay on the list prices of their branded products from 7% to 15.5%, according to a Bundestag announcement on July 10. That said, a variable rebate proposal, which the Bundestag noted was “intended to generate regular additional revenue in the long term,” has been nixed from the plan following industry opposition earlier this summer. 

By passing the reforms, Germany is aiming to save some 16.3 billion euros ($18.6 billion) in costs across its statutory health insurance system next year, with the potential to lift that figure to upwards of 38.1 billion euros ($43.5 billion) by 2030. 

Earlier this year, pharma bigwigs Eli Lilly and local drugmaker Boehringer Ingelheim said they were cutting back on separate planned investments in Germany in light of drug discount measures included in the country’s health insurance reform efforts. 

The proposals earlier this year also attracted criticism from leadership at Euro pharma powerhouse Novartis and New York drugmaker Pfizer, among others. 

In a small win for the industry, however, Germany in mid-June moved to nix plans for a variable drug discount structure, Reuters reported at the time, opting instead for the fixed rebate plan included in Friday’s measure. 

Germany is a key market for branded drugmakers in Europe, due in no small part to the fact that the country’s quick reimbursement turnaround supports some of, if not the earliest potential launch timing for novel medicines in the bloc. 

Despite the victory on the variable discount front, Germany’s top trade group representing drugmakers, the Association of Research-Based Pharmaceutical Companies (VFA), came out swinging against the passage of the reform measures late last week, warning (German) that the insurance reforms will place a “considerable burden on the research-based pharmaceutical industry and the medical care of the population in Germany.” 

The trade group alleges that, “during the parliamentary process, key burdens on pharmaceutical companies were not reduced but rather further intensified,” caveating that “[w]hile other stakeholders have received some relief, the burdens on the pharmaceutical industry are set to increase in several areas.” 

Putting things into perspective, VFA estimates that the fixed manufacturer discount rate of 15.5% will jack up the “burden on industry” from an originally expected 1.1 billion euros to roughly 3.2 billion euros “in 2027 alone.” 

VFA also took umbrage with price-quantity regulation and an increase on discounts for vaccines, specifically, in a statement late Friday. 

The reform movement in Germany comes as U.S. trade policy—driven by the Trump administration’s tariff threats and drug pricing reforms in the shape of the White House’s “most favored nation” framework—thrusts the competitiveness and pricing policies of other wealthy nations into the spotlight. 

Speaking to the German efforts earlier this year, Novartis helmsman Vas Narasimhan told reporters in late April that “[p]olicies like this send the wrong signal to a high innovation industry like ours, where we see U.S. and China actively investing in the biotech ecosystem to make it highly competitive.”

https://www.fiercepharma.com/pharma/germany-pushes-through-healthcare-reform-package-despite-pharmas-drug-discount-resistance

FDA's latest onshoring move homes in on streamlined facility registration, foreign plant scrutiny

 In an initiative to increase the efficiency of drug manufacturing in the United States, the FDA has proposed a streamlined pathway for registering production facilities that operate under a “hub-and-spoke” model.

The new rule would cut red tape, allowing manufacturing entities that have equivalent production units at different locations to register as a single establishment instead of having each unit register and gain clearance separately.

“The FDA is proposing changes to our establishment registration regulations that would reflect how distributed manufacturing actually works—as one single establishment,” Michael Davis, M.D., Ph.D., the acting director of FDA’s Center for Drug Evaluation and Research, said in a release. “The proposed changes would make it easier for innovative manufacturers to operate efficiently, and give the FDA a clearer, more accurate picture of how and where drugs are being made.”

The proposal would reduce registration costs for manufacturers and generate “long-term efficiencies for both industry and the agency,” the FDA said.

The U.S. regulator also proposes to clarify the registration requirements for foreign manufacturers, especially those who make active pharmaceutical ingredients (API). The FDA noted that, as things stand, some foreign manufacturing facilities that only distribute to other foreign establishments currently may not be registered with the regulator, limiting its visibility toward "upstream supply chains."

The proposal would force such establishments to register with the FDA and report what they produce. The agency said that the documentation of these manufacturers would allow it to detect and respond to safety issues.

The agency estimates (PDF) that there are 25 unregistered foreign manufacturers that produce ingredients for branded drugs that are sold in the U.S. and 1,600 unregistered manufacturers who make components for over-the-counter treatments. 

The FDA “should be able to trace exactly” where ingredients in medicines come from, Davis added. “Closing this registration gap for foreign establishments is a concrete step toward increasing the supply chain transparency that patients deserve.”

Since taking office in his second term, President Donald Trump has pushed to reduce the reliance of the U.S. on foreign imports, including drugs. The administration has made deals with many of the industry's biggest drug manufacturers, reducing their exposure to tariffs in exchange for commitments to build manufacturing facilities in the U.S.

Last month, biopharma giants Eli Lilly and Regeneron, as well as rapidly growing contract manufacturers Fujifilm Biotechnologies and Cellares, were among seven companies selected by the FDA for its PreCheck Pilot Program, another initiative designed to strengthen drug manufacturing and bolster supply chain resilience in the United States.

https://www.fiercepharma.com/manufacturing/fda-moves-streamline-registration-drug-manufacturing-facilities-us

Biotech Stocks At 52-Week Highs: AMWL, CUE, ICCC, SRRK, FTH

 The following biotech stocks touched a 52-wek high on July 10, 2026, driven by key catalysts like encouraging regulatory updates and quarterly results.

American Well Corporation (AMWL)

American Well, or Amwell, designs and provides software solutions for various healthcare services. Amwell hit a 522-week high of $10.16 on Friday, closing the day at $9.91, up 8.66%.

A recent Nature report validated the company's SilverCloud platform as a digital mental health solution. Amwell also facilitated DarioHealth in signing an agreement to gain new insurers.

For full-year 2026, the company expects revenue of $195 million to $205 million, below the $249.3 million reported in 2025.

Cue Biopharma Inc. (CUE)

Cue Biopharma is a clinical-stage biopharmaceutical company developing therapies for immunological disorders. The company reached a 52-week high of $45.50 in intraday trading on Friday.

On the same day, a private placement worth about $50 million in gross proceeds was announced by the company via a securities purchase agreement with private investors.

Cue is currently advancing CUE-221, an anti-IgE antibody with a dual-mechanism action in a Phase 2 study for the treatment of allergic diseases, and previously expressed intentions to expand the drug's eligibility to food allergy treatments.

The company has also established the Immuno-STAT platform which selectively targets disease-specific T cells in vivo without broad immune modulation. An investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA) is planned for CUE-401, a candidate for treating autoimmune diseases.

ImmuCell Corporation (ICCC)

ImmuCell, an animal health biologics company, on Friday climbed to a 52-week high of $11.59 in intraday trading.

The company reported unaudited second-quarter sales of $7.2 million, representing an 11.5% year-over-year increase. A significant contributor to this was the $4.9 million from sales of the Tri-Shield First Defense, which is used to prevent scours in newborn calves.

A conference call to discuss revenue drivers and complete financial results is slated to be hosted on Friday, August 14, 2026, at 9:00 AM ET.

Scholar Rock Holding Corp.(SRRK)

Scholar Rock is a biopharmaceutical company that specializes in developing therapies for spinal muscle atrophy (SMA) and other neuromuscular, hematological, and fibrotic diseases. In Friday's trade, the stock reached a 52-week high of $58.49, up 3.33 % from the previous close.

The company previously announced the acceptance of its biologics license application (BLA) for Apitegromab in treating SMA. A response from the FDA is anticipated by September 30, 2026.

The company is also assessing various therapies targeting latent tumor growth factor beta for the treatment of cancers and fibrotic diseases.

Faeth Therapeutics Inc. (FTH)

Shares of Faeth Therapeutics touched a 52-week high of $36.89 during intraday trading on Friday.

The company, formerly known as Sensei Biotherapeutics, is advancing the combination therapy PIKTOR for the treatment of HR+/HER- breast cancer in a Phase 1/2 trial, with interim data expected in 2027.

The therapy is also being evaluated in a Phase 2 trial for endometrial cancer, with topline data expected in the second half of 2026.

https://www.rttnews.com/3666350/biotech-stocks-at-52-week-highs-amwl-cue-iccc-srrk-fth.aspx

Iranian threats against Italian leaders are unacceptable, Tajani says

 

Iranian threats against Italian leaders are unacceptable, Italian Foreign Minister Antonio Tajani told Iran International on Monday.

“It is unacceptable. Italy is not fighting against Iran, so we do not understand this attack against Italy,” Tajani said on the sidelines of an EU Foreign Affairs Council meeting in Brussels.

On Saturday, Tehran municipality-affiliated newspaper Hamshahri published an image of 13 world leaders, including Italian Prime Minister Giorgia Meloni, claiming they were on the Islamic Republic’s revenge list.

Tajani said Italy supported democracy, peace and freedom of navigation, describing any effort to block the Strait of Hormuz as a major mistake.

“Freedom of navigation is crucial for us,” he said. “On this, we support the American position, not the Iranian position.”

https://www.iranintl.com/en/liveblog/202607116587

Massachusetts man convicted of illegally exporting electronics to Iran - AP

 

A Massachusetts man was found guilty of conspiring to unlawfully export electronic components to Iran in violation of US sanctions, the Associated Press reported.

“At its core, this case is straightforward. You cannot send goods, especially the goods at issue in this case, to Iran. Period. Full stop,” Assistant US Attorney Alathea Porter told jurors.

Mahdi Mohammad Sadeghi, a 43-year-old naturalized US citizen and former employee of global electronics company Analog Devices, was convicted on three of five charges.

Prosecutors accused Sadeghi of helping Iranian business associate Mohammad Abedininajafabadi evade US export controls through a front company in Switzerland.

They said Abedini’s Tehran-based company produces navigation systems for the military drone program of Iran’s Revolutionary Guard.

https://www.iranintl.com/en/liveblog/202607116587

Pezeshkian urges faster implementation of Iran-Russia agreements

 

Iranian President Masoud Pezeshkian told Russia’s energy minister that Tehran was ready to remove obstacles delaying joint projects with Moscow, calling for strategic agreements between the two countries to move rapidly from negotiations to implementation.

Speaking during a meeting with Sergei Tsivilev on Monday, Pezeshkian highlighted cooperation in energy, oil, gas, petrochemicals, industry, trade and transit corridors.

He said the political will expressed by senior officials, including Russian President Vladimir Putin, meant joint projects should not be allowed to proceed slowly.

Pezeshkian also pointed to opportunities for cooperation through BRICS, the Shanghai Cooperation Organization, the Eurasian Economic Union and frameworks involving Caspian Sea states.

https://www.iranintl.com/en/liveblog/202607116587

Houthis vow targeting S. Arabia's 'vital' infrastructure

 A political bureau member of Yemen's Houthis, Mohammad al-Bukhaiti, stated on Monday that the military group will respond to an attack on Sanaa International Airport.

In a video statement carried by local media, the Houthi senior official announced that the military group will target Saudi Arabia's "vital" infrastructure.

Various media also reported that a new barrage of missiles was launched from Yemen towards Saudi Arabia, targeting Abha International Airport and King Khalid Air Base in Khamis Mushait.

https://breakingthenews.net/Article/Houthis-vow-targeting-S.-Arabia's-'vital'-infrastructure/66687077